First-in-Man Use of the Percutaneous 10F Reitan Catheter Pump for Cardiorenal Syndrome.

Cardiorenal syndrome worsens outcome in patients with decompensated chronic heart failure, and complicates recompensation by medical therapy. Mechanical circulatory support has the potential to improve renal function, and likely mitigates diuretic resistance in patients with severe cardiorenal syndrome. The Reitan catheter pump (RCP) is a novel temporary percutaneous circulatory support system for reducing cardiac afterload and increasing renal preload. Here, we report on the first-in-man use of the 10F-version of the RCP device, which was associated with favorable effects on hemodynamics and diuresis. Further investigation to evaluate safety and efficacy of this promising approach is warranted.

Percutaneous haemodynamic and renal support in patients presenting with decompensated heart failure: A multi-centre efficacy study using the Reitan Catheter Pump (RCP).

BACKGROUND: Worsening heart failure complicated by congestion, hypotension, and renal dysfunction is difficult to manage, increasingly common and predicts a poor outcome. Novel therapies are required to facilitate diuresis and implementation of disease-modifying interventions in preparation for hospital discharge. Accordingly, we investigated the haemodynamic and renal effects of the Reitan Catheter Pump (RCP) percutaneous support device in patients admitted with decompensated heart failure (DHF). METHODS: This was a prospective observational study of 20 patients admitted with DHF, ejection fraction < 30%, and Cardiac index (CI) < 2.1 L/min/m2 in need of inotropic/mechanical support. RESULTS: Patients underwent RCP support for a mean of 18.3 (±6.3) hours. The RCP increased CI from 1.84 L/min/m2 (±0.27), to 2.41 L/min/m2 (±0.45, p = 0.04), increased urine output (71 mL/h (±65) to 227 ml/h (±179) (p = 0.006) with a concomitant reduction in serum creatinine (188 µmol/L (±87) to 161 µmol/L (±78) (p = 0.0007). There were no clinically significant haemolysis, vascular injury, or thrombo-embolic complications. CONCLUSIONS: For patients admitted with DHF, the RCP improves cardiac index, diuresis and renal function without causing important complications.

Longitudinal evaluation of ventricular ejection fraction and NT-proBNP across heart failure subgroups.

OBJECTIVES: Left ventricular ejection fraction (EF) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) are important surrogate markers of cardiac function and wall stress. Randomized trials of heart failure (HF) have shown improvements in survival in patients with reduced EF (<40%, HFrEF) but not with preserved EF (≥50%, HFpEF) or mid-range EF (40-49%, HFmrEF). Limited information is available on the trajectory of EF in contemporary heart failure management programs (HFMPs). DESIGN: 201 HF patients consecutively enrolled 2010-2011 in the outpatient-based HFMP of Skåne University Hospital in Lund were included in the study. Probable etiology, EF, NT-proBNP and medications were assessed at baseline and 1 year after enrollment. RESULTS: HFrEF was the most common heart failure subgroup (78.1% of patients) in this HFMP, followed by HFmrEF (14.9%) and HFpEF (7.0%). The most common etiology was ischemic heart disease (IHD, 40.8%). Complete recovery of EF (>50%) was rare (14.1% of patients with HFrEF and 26.7% with HFmrEF), some degree of improvement was observed in 57.7% and 46.7% of patients. LVEF improved on average 9.1% in patients with HFrEF (p < .001) and NT-proBNP decreased from 4,202 to 2,030 pg/ml (p < .001). A similar trend was noticed for the HFmrEF group but was not statistically significant. The improvement in LVEF was consistent across subgroups with HF attributable to IHD (6.2%), idiopathic dilated cardiomyopathy (7.1%) and tachycardia-induced HF (17.5%). CONCLUSIONS: This study provides estimates of the improvement in LVEF and NT-proBNP that can be expected with contemporary management across subgroups of HF and different etiologies in a contemporary HFMP.

Orthogonal P-wave morphology is affected by intra-atrial pressures.

BACKGROUND: It has previously been shown that the morphology of the P-wave neither depends on atrial size in healthy subjects with physiologically enlarged atria nor on the physiological anatomical variation in transverse orientation of the left atrium. The present study aimed to investigate if different pressures in the left and right atrium are associated with different P-wave morphologies. METHODS: 38 patients with isolated, increased left atrial pressure, 51 patients with isolated, increased right atrial pressure and 76 patients with biatrially increased pressure were studied. All had undergone right heart catheterization and had 12-lead electrocardiographic recordings, which were transformed into vectorcardiograms for detailed P-wave morphology analysis. RESULTS: Normal P-wave morphology (type 1) was more common in patients with isolated increased pressure in the right atrium while abnormal P-wave morphology (type 2) was more common in the groups with increased left atrial pressure (P = 0.032). Moreover, patients with increased left atrial pressure, either isolated or in conjunction with increased right atrial pressure, had significantly more often a P-wave morphology with a positive deflection in the sagittal plane (P = 0.004). CONCLUSION: Isolated elevated right atrial pressure was associated with normal P-wave morphology while left-sided atrial pressure elevation, either isolated or in combination with right atrial pressure elevation, was associated with abnormal P-wave morphology.

Chronic kidney disease after heart transplantation: a single-centre retrospective study at Skåne University Hospital in Lund 1988-2010.

We aimed to study the incidence, predictors and outcome of chronic kidney disease (CKD) after heart transplantation (HT). All our HT patients 1988-2010 were considered for inclusion. Of these, 134 came for annual follow-ups including evaluation of glomerular filtration rate (GFR) using iohexol clearance measurements, and the CKD-EPI (adults) or Schwartz (children) formulae. Median GFR (Q1-Q3) (ml/min/1.73 m(2) ) declined from 67.0 (50.0-82.0) during transplant assessment (TA) to 56.0 (45.0-69.0) at year 1, 53.0 (41.0-68.0) at year 5 and 44.5 (25.0-57.3) at year 10. The cumulative incidence of CKD ≥ stage 4 was 25% at 5 years and 41% at 10 years after transplantation. Proteinuria the first year post-HT was the only predictor related (P < 0.05) to a higher rate of GFR decline (HR 5.15, 95% CI 1.23-21.55). GFR ≥60 as compared to <60 before HT, or a first-year GFR decline <30% as compared to >30%, was moreover associated (P < 0.05) with a lower risk of death (HR 0.30, 95% CI 0.12-0.76 and HR 0.35, 95% CI 0.13-0.90, respectively). Notably, the CKD-EPI and Schwartz formulae overestimated GFR by 28 ± 29% and 26 ± 33%, respectively. In conclusion, CKD in HT patients is common and associated with worse outcome. To avoid diagnostic delay, GFR estimating equations' validity in HT patients needs further study.

A first-in-man study of the Reitan catheter pump for circulatory support in patients undergoing high-risk percutaneous coronary intervention.

OBJECTIVES: To investigate the safety of a novel percutaneous circulatory support device during high-risk percutaneous coronary intervention (PCI). BACKGROUND: The Reitan catheter pump (RCP) consists of a catheter-mounted pump-head with a foldable propeller and surrounding cage. Positioned in the descending aorta the pump creates a pressure gradient, reducing afterload and enhancing organ perfusion. METHODS: Ten consecutive patients requiring circulatory support underwent PCI; mean age 71 +/- 9; LVEF 34% +/- 11%; jeopardy score 8 +/- 2.3. The RCP was inserted via the femoral artery. Hemostasis was achieved using Perclose sutures. PCI was performed via the radial artery. Outcomes included in-hospital death, MI, stroke, and vascular injury. Hemoglobin (Hb), free plasma Hb (fHb), platelets, and creatinine (cre) were measured pre PCI and post RCP removal. RESULTS: The pump was inserted and operated successfully in 9/10 cases (median 79 min). Propeller rotation at 10,444 +/- 1,424 rpm maintained an aortic gradient of 9.8 +/- 2 mm Hg. Although fHb increased, there was no significant hemolysis (4.7 +/- 2.4 mg/dl pre vs. 11.9 +/- 10.5 post, P = 0.04, reference 20 mg/dl). Platelets were unchanged (pre 257 +/- 74 x 10(9) vs. 245 +/- 63, P = NS). Renal function improved (cre pre 110 +/- 27 micromol/l vs. 99 +/- 28, P = 0.004). The RCP was not used in one patient following femoral introducer sheath related aortic dissection. All PCI procedures were successful with no deaths or strokes, one MI, and no vascular complications following pump removal. CONCLUSIONS: The RCP can be used safely in high-risk PCI patients. This device may be an alternative to other percutaneous systems when substantial cardiac support is needed.

Hemodynamic effects of a new percutaneous circulatory support device in a left ventricular failure model.

We have tested a new percutaneous circulatory support device in seven anesthetized calves with induced left ventricular failure. The device is based on a flexible catheter with a foldable propeller and cage at the distal end. The rotation of the propeller (1,000-15,000 rpm) is transmitted from a drive unit at the proximal end to the propeller by way of a rotating wire inside the catheter. This also contains an umbrella-like mechanism to open the pump head from the folded (diameter 4.6 mm) to the active position. The rotation of the propeller creates a pressure drop in front of the propeller and a pressure rise behind. Heart failure was induced with metoprolol and verapamil in combination with a VVI pacemaker to create a left atrial pressure greater than 20 mm Hg. A centrifugal pump was used to bypass the right ventricle and to ensure a sufficient filling of the left ventricle. After baseline recordings, the pump was run at 14,000 rpm, and the hemodynamic response was compared with the baseline. A 24 +/- 10 mm Hg pressure gradient was generated across the pump, resulting in a drop in the right carotid artery mean pressure from 80 +/- 11 to 71 +/- 13 mm Hg (p = 0.008) and a drop in the left ventricular systolic pressure from 109 +/- 17 to 100 +/- 19 mm Hg (p = 0.004). The pressure in the left atrium decreased from 25 +/- 3 to 20 +/- 5 mm Hg (p = 0.008). The mean femoral pressure increased from 78 +/- 10 to 95 +/- 20 mm Hg (p = 0.005). A moderate reduction in the right carotid flow was observed (15%, p = 0.029), whereas no significant changes were found in the coronary flow, the flow in the right femoral artery, or in the left kidney. The device showed a significant unloading of the left ventricle and an increased perfusion pressure for the lower part of the body. The moderate changes in flow were probably caused by still active autoregulation, and this needs to be tested with more pronounced circulatory failure.

Left ventricular heart failure model for testing cardiac assist devices.

During the development of a new circulatory support system, we have used different animal models with and without heart failure for hemodynamic testing. As the normally functioning heart does not always allow for proper evaluation of a circulatory support system, a good and adjustable animal heart failure model is needed. The aim of the study was to develop a left ventricular failure model in calves for acute hemodynamic studies. The principle is based on the negative inotropic effect of drugs with bypass of the right ventricle. Seven calves were used in the study. Metoprolol and verapamil were both given intravenously as a bolus, and verapamil was continued as an infusion. The animals were equipped with a VVI pacemaker to treat the expected arteriovenous blockade. A centrifugal pump provided an adjustable flow with a two-stage inflow cannula draining both the upper and lower caval veins and with the outflow cannula in the pulmonary artery. The pump counteracted the effects of right ventricular failure and enabled us to increase the left atrial pressure to more than 20 mm Hg. Pressure in the left atrium rose from 5+/-3 to 25+/-4 mm Hg (p < 0.001), the left ventricular diastolic pressure increased from 2+/-3 to 17+/-7 mm Hg (p = 0.003), and the mean pulmonary pressure increased from 17+/-5 to 33+/-5 mm Hg (p < 0.001). Cardiac output was not significantly changed from 4.0+/-0.8 L/min in the healthy animals to 3.5+/-0.5 L/min (p = 0.25) in failure. The model allowed us to create an adjustable and isolated left ventricular failure well suited for short-term hemodynamic testing of a left ventricular support device.