Direct left atrial pressure monitoring in severe heart failure: long-term sensor performance.

We report the stability, accuracy, and development history of a new left atrial pressure (LAP) sensing system in ambulatory heart failure (HF) patients. A total of 84 patients with advanced HF underwent percutaneous transseptal implantation of the pressure sensor. Quarterly noninvasive calibration by modified Valsalva maneuver was achieved in all patients, and 96.5% of calibration sessions were successful with a reproducibility of 1.2 mmHg. Absolute sensor drift was maximal after 3 months at 4.7 mmHg (95% CI, 3.2-6.2 mmHg) and remained stable through 48 months. LAP was highly correlated with simultaneous pulmonary wedge pressure at 3 and 12 months (r = 0.98, average difference of 0.8 ± 4.0 mmHg). Freedom from device failure was 95% (n = 37) at 2 years and 88% (n = 12) at 4 years. Causes of failure were identified and mitigated with 100% freedom from device failure and less severe anomalies in the last 41 consecutive patients (p = 0.005). Accurate and reliable LAP measurement using a chronic implanted monitoring system is safe and feasible in patients with advanced heart failure.

Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure.

BACKGROUND: Previous studies suggest that management of ambulatory hemodynamics may improve outcomes in chronic heart failure. We conducted a prospective, observational, first-in-human study of a physician-directed patient self-management system targeting left atrial pressure. METHODS AND RESULTS: Forty patients with reduced or preserved left ventricular ejection fraction and a history of New York Heart Association class III or IV heart failure and acute decompensation were implanted with an investigational left atrial pressure monitor, and readings were acquired twice daily. For the first 3 months, patients and clinicians were blinded as to these readings, and treatment continued per usual clinical assessment. Thereafter, left atrial pressure and individualized therapy instructions guided by these pressures were disclosed to the patient. Event-free survival was determined over a median follow-up of 25 months (range 3 to 38 months). Survival without decompensation was 61% at 3 years, and events tended to be less frequent after the first 3 months (hazard ratio 0.16 [95% confidence interval 0.04 to 0.68], P=0.012). Mean daily left atrial pressure fell from 17.6 mm Hg (95% confidence interval 15.8 to 19.4 mm Hg) in the first 3 months to 14.8 mm Hg (95% confidence interval 13.0 to 16.6 mm Hg; P=0.003) during pressure-guided therapy. The frequency of elevated readings (>25 mm Hg) was reduced by 67% (P<0.001). There were improvements in New York Heart Association class (-0.7+/-0.8, P<0.001) and left ventricular ejection fraction (7+/-10%, P<0.001). Doses of angiotensin-converting enzyme/angiotensin-receptor blockers and beta-blockers were uptitrated by 37% (P<0.001) and 40% (P<0.001), respectively, whereas doses of loop diuretics fell by 27% (P=0.15). CONCLUSIONS: Physician-directed patient self-management of left atrial pressure has the potential to improve hemodynamics, symptoms, and outcomes in advanced heart failure. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00547729.

Assessment of a novel angiographic image stabilization system for percutaneous coronary intervention.

BACKGROUND: Optimization of coronary images for percutaneous coronary intervention (PCI) remains difficult due to cardiac motion throughout the respiratory and cardiac cycles. We tested a novel system to stabilize angiographic images at the region of interest in order to assist during PCI. METHODS: Patients undergoing PCI to the right coronary artery (RCA) (group 1, n = 22) or complex PCI (group 2, n = 16) were prospectively enrolled and the angiographic image sequences of patients who died suddenly of confirmed or presumed stent thrombosis following PCI (group 3, n = 16) were retrospectively reviewed. All image sequences were analyzed off-line by three cardiologists before and after image stabilization for accuracy of stent placement, presence of residual edge dissection, and adequacy of procedural outcome. RESULTS: Image stabilization was successful in 100% of cases in a mean time of 95 +/- 71 seconds and was considered to be helpful in 13.6% of group 1, in 18.3% of group 2, and in 10% of group 3 cases. There was good correlation between observers with a kappa statistic of 0.85 to 1.0 for all observations. However, there was no difference in the reviewers' opinions of stent placement, presence of edge dissection, or adequacy of procedural result when comparing the standard angiographic views and the stabilized images. In particular, no previously unrecognized edge dissections were apparent in group 3 with stabilized display. CONCLUSION: Image stabilization centered on the region of interest was considered helpful in a small subset of patients, particularly the complex PCI patients. However, no differences in objective parameters could be demonstrated.

Noninvasive calibration of cardiac pressure transducers in patients with heart failure: an aid to implantable hemodynamic monitoring and therapeutic guidance.

BACKGROUND: Implantable cardiac pressure monitors require assurance of calibration. This study evaluated if airway pressure responses during Valsalva maneuver (VM) can be used for calibrating intracardiac pressure transducers. METHODS AND RESULTS: Thirty-eight heart failure patients performed VMs while cardiac and airway pressures were recorded. Patients were designated as Lower (L) if baseline PCW was <20 mm Hg (n = 17); otherwise, they were categorized as Higher (H) (n = 21). VMs were repeated in 9 H patients after nitroglycerin. Procedural success was 92% and there were no complications. Differences between filling pressure and airway pressure (effective pressure) were eliminated during VM (RA(eff) = -0.9 +/- 1.3, RVED(eff) = 1.2 +/- 1.1, PCW(eff) = 2.1 +/- 2.8, and LVED(eff) = 0.9 +/- 1.6 mm Hg), and filling pressures were highly correlated with airway pressure r = 0.94. On average, group H had higher PCW(eff) and LVED(eff) than L patients by 1.8 and 2.5 mm Hg (P < or = .002), respectively, but after nitrates their responses were identical. CONCLUSION: The relationships between cardiac filling pressure and airway pressure during the Valsalva maneuver are sufficiently reliable to be considered as a new, noninvasive method for establishing the calibration of cardiac pressure sensors in patients with heart failure.

Improved localization of coronary stents using layer decomposition.

Accurate placement and expansion of coronary stents is hindered by the fact that most stents are only slightly radiopaque and hence difficult to see in typical coronary X-ray images. We propose a new technique for improved image guidance of multiple coronary stent deployment using layer decomposition of coronary X-ray image sequences. We hypothesize that layer decomposition can improve the accuracy of localization of the end of a deployed stent. Layer decomposition is used to obtain good quality images of a stent in vitro. The resultant background-subtracted stent images are embedded into other cine X-ray image sequences to form a database of simulated image sequences. For each simulated sequence, the position of the stent edge is estimated from raw and layer-decomposed images using a small region of the original layer image as a template. Layer decomposition reduced median position errors in 33 of 47 image sequences (70%), including 16 of 18 sequences in which the position errors for raw and layer images differed by 5.0 pixels (0.5 mm) or more. Layer decomposition significantly reduces errors in determination of stent edge location in simulated cine X-ray image sequences.

Evaluation of layer decomposition for multiframe quantitative coronary angiography.

Multiframe quantitative coronary angiography is typically performed by averaging measurements of artery diameter over multiple frames. This approach reduces errors attributable to random noise but may not reduce systematic errors caused by background structures, nonlinear system response, and motion blur. We attempt to reduce these sources of error by decomposing the image sequence into moving layers, one of which includes the artery. We embed simulated arteries into clinical angiographic sequences so that the true vessel dimensions are known accurately. The measurement tasks are minimum diameter, geometric percent stenosis, and densitometric percent stenosis. We compare measurements for single and multiple raw images, single images with fixed mask subtraction, single and multiple images with layered background subtraction, and time-averaged layer images. We find that both multiframe averaging and layer decomposition significantly improve geometric and densitometric accuracy compared with single-frame measurements. The best results were obtained by averaging measurements from multiple frames of layered background-subtracted images.

Validation of the localization of the target tissue for intracoronary brachytherapy.

In a previous meta-analysis of intracoronary brachytherapy (ICBT) studies, we identified the target tissue at 0.6 to 0.7 mm tissue depth and we developed two models, describing the relationship between dose and ICBT effectiveness. The purpose of the present study was to validate the identified target tissue depth and the developed dose models, using the results of 1) two prospective animal studies with ICBT, 2) a retrospective analysis of animal studies with external beam irradiation and 3) results of recent clinical ICBT trials. ICBT effectiveness in the porcine restenosis studies was quantified as inhibition of neointima proliferation. The results of these studies were correlated with the developed dose-effectiveness model. Finally, the agreement of the restenosis rates of the recent clinical trials with the developed dose-restenosis model was tested. The porcine restenosis studies demonstrated a dose-related inhibition of neointima proliferation. The radiation effectiveness of both prospective studies and the effectiveness of the studies with external beam irradiation demonstrated the best agreement with the developed dose model at a tissue depth of 0.6 mm. Furthermore, the restenosis rates of the recent clinical ICBT studies were in concordance with the developed dose-restenosis model. In conclusion, the current study validated the localization of the target tissue for ICBT at a tissue depth of 0.6 to 0.7 mm as well as the relationship between dose and ICBT effectiveness at this depth. The data provide a rationale for setting a common dose prescription point at 0.6 to 0.7 mm tissue depth.