Fecobionics in proctology: review and perspectives.

Fecobionics is a novel integrated technology for assessment of anorectal function. It is a defecatory test with simultaneous measurements of pressures, orientation, and device angle (a proxy of the anorectal angle). Furthermore, the latest Fecobionics prototypes measure diameters (shape) using impedance planimetry during evacuation of the device. The simultaneous measurement of multiple variables in the integrated test allows new metrics to be developed including more advanced novel defecation indices, enabling mechanistic insight in the defecation process at an unprecedented level in patients with anorectal disorders including patients suffering from obstructed defecation, fecal incontinence, and low anterior resection syndrome. The device has the consistency and shape of a normal stool (type 3-4 on the Bristol Stool Form Scale). Fecobionics has been validated on the bench and in animal studies and used in clinical trials to study defecation phenotypes in normal human subjects and patients with obstructed defecation, fecal incontinence, and low anterior resection syndrome after rectal cancer surgery. Subtypes have been defined, especially of patients with obstructed defecation. Furthermore, Fecobionics has been used to monitor biofeedback therapy in patients with fecal incontinence to predict the outcome of the therapy (responder versus non-responder). Most Fecobionics studies showed a closer correlation to symptoms as compared to current technologies for anorectal assessment. The present article outlines previous and ongoing work, and perspectives for future studies in proctology, including in physiological assessment of function, diagnostics, monitoring of therapy, and as a tool for biofeedback therapy.

Calcium phosphate supplementation increases faecal Lactobacillus spp. in a randomised trial of young adults.

The aim of the studies was to determine the effects of calcium carbonate and calcium phosphate supplementation on faecal Lactobacillus spp., with and without a probiotic supplement, in healthy adults. Study 1 comprised of a randomised, double-blind, crossover design; participants (n=15) received 2 capsules/d of 250 mg elemental calcium as calcium carbonate (Ca1) and calcium phosphate (Ca2) each for 2-week periods, with 2-week baseline and washout periods. Study 2 was a randomised, double-blind, crossover design; participants (n=17) received 2 capsules/d of Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011 (probiotic) alone, the probiotic with 2 capsules/d of Ca1, and probiotic with 2 capsules/d of Ca2 each for 2-week periods with 2-week baseline and washout periods. In both studies, stools were collected during the baseline, intervention and washout periods for Lactobacillus spp. quantification and qPCR analyses. Participants completed daily questionnaires of stool frequency and compliance. In Study 1, neither calcium supplement influenced viable counts of resident Lactobacillus spp., genome equivalents of lactic acid bacteria or stool frequency. In Study 2, faecal Lactobacillus spp. counts were significantly enhanced from baseline when the probiotic was administered with Ca2 (4.83±0.30, 5.79±0.31) (P=0.02), but not with Ca1 (4.98±0.31) or with the probiotic alone (5.36±0.31, 5.55±0.29) (not significant). Detection of L. helveticus R0052 and L. rhamnosus R0011 was significantly increased with all treatments, but did not differ among treatments. There were no changes in weekly stool frequency. Calcium phosphate co-administration may increase gastrointestinal survival of orally-administered Lactobacillus spp.

A transatrial pericardial access: lead placement as proof of concept.

A safe, easy, and quick access into the pericardial space may provide a window for diagnostics and therapeutics to the heart. The objective of this study was to provide proof of concept for an engagement and access catheter that allows access to the pericardial space percutaneously. A multilumen catheter was developed to allow navigation and suction fixation to the right atrial appendage/wall in a normal swine model. Advancement through the multilumen catheter using a second catheter with a distal needle tip allows access to the pericardial space without pericardial puncture and advancement of a standard guide wire into the space. Navigation into the pericardial space was undertaken by fluoroscopy alone and was accomplished in 10 swine (5 acute and 5 chronic). As a specific application of this pericardial access method, a pacing lead was implanted on the epicardial surface. Five chronic swine experiments were conducted with successful pacing engagement verified by lead impedance and pacing threshold and sensing. Lead impedance exceeded 1,000 Omega preengagement and dropped by an average of 200 Omega upon implant (769 +/- 498 Omega). Pacing thresholds at 0.4 ms ranged from approximately 0.5 to 2.1 V acutely (1.03 +/- 0.92 V). No cardiac effusion or tamponade was observed in any of the acute or chronic studies. The ability to engage, maintain, and retract the right atrial appendage/wall and to engage an epicardial lead was successfully demonstrated. These findings support the feasibility of safe access into the pericardial space in a normal swine model and warrant further investigations for clinical translation.

Predictors of chronotropic incompetence in the pacemaker patient population.

AIMS: We prospectively evaluated results from cardiopulmonary exercise testing for chronotropic incompetence (CI) in a cohort of 292 pacemaker patients. In addition, we evaluated comorbidity and antiarrhythmic patient data as indicators of CI. METHODS AND RESULTS: On the basis of exercise stress testing and application of the definition of CI by Wilkoff, 51% of our cohort was categorized as having CI. Indications for pacemaker implant for this patient group were 42% atrioventricular block, 56% sinus node disease, and 59% atrial fibrillation. Maximum oxygen uptake (VO(2) max) and exercise duration were significantly reduced among CI pacemaker patients, whereas oxygen uptake at the anaerobic threshold remained unchanged. The following clinical characteristics were significant predictors of CI: existence of coronary artery disease (P = 0.038), presence of an acquired valvular heart disease (P = 0.037), and former cardiac surgery (P = 0.041). Age, gender, arterial hypertension, cardiomyopathy, congenital heart disease, left ventricular ejection fraction, and time period between stress-exercise examination and pacemaker implantation were not significant predictors of CI. Chronic antiarrhythmic therapy with digitalis (P = 0.013), beta blockers (P = 0.036), and amiodarone (P = 0.045) were significant predictors of CI. In contrast, medication with class I and IV antiarrhythmics had no significant correlation with CI. CONCLUSION: We found the following characteristics predictive of CI in this pacemaker patient population: VO(2) max, existence of coronary artery disease or acquired valvular heart disease, previous cardiac surgery, as well as medication with digitalis, beta blockers, and amiodarone.

Echocardiographic AV-interval optimization in patients with reduced left ventricular function.

BACKGROUND: Ritter's method is a tool used to optimize AV delay in DDD pacemaker patients with normal left ventricular function only. The goal of our study was to evaluate Ritter's method in AV delay-interval optimization in patients with reduced left ventricular function. METHODS: Patients with implanted DDD pacemakers and AVB III degrees were assigned to one of two groups according to ejection fraction (EF): Group 1 (EF > 35%) and Group 2 (EF < 35%). AV delay optimization was performed by means of radionuclide ventriculography (RNV) and application of Ritter's method. RESULTS: For each of the patients examined, we succeeded in defining an optimal AV interval by means of both RNV and Ritter's method. The optimal AV delay determined by RNV correlated well with the delay found by Ritter's method, especially among those patients with reduced EF. The intra-class correlation coefficient was 0.8965 in Group 1 and 0.9228 in Group 2. The optimal AV interval in Group 1 was 190 +/- 28.5 ms, and 180 +/- 35 ms in Group 2. CONCLUSION: Ritter's method is also effective for optimization of AV intervals among patients with reduced left ventricular function (EF < 35%). The results obtained by RNV correlate well with those from Ritter's method. Individual programming of the AV interval is fundamentally essential in all cases.

R-wave detection by subcutaneous ECG. Possible use for analyzing R-R variability.

BACKGROUND: Atrial arrhythmia (AA) discrimination remains a technological challenge for implanted cardiac devices. We examined the feasibility of R-wave detection by a subcutaneous far field ECG (SFFECG) and analysis of these signals for R to R variability as an indicator of atrial arrhythmia (AA). METHODS: Surface ECG and SFFECG (from the pacemaker pocket) were recorded in sixteen patients (61.5 +/- 11.4 years) with AA. The SFFECG was recorded with a pacemaker sized four electrode array acutely placed in the pacemaker pocket during implantation. The signals were analyzed to obtain peak-to-peak R wave amplitude and R to R interval variability (indicative of AAs). RESULTS: In sixteen patients R waves were visually discernible in all recordings. The percentage over and under detection for automatic R wave recognition SFFECG was 3 and 9%, respectively. R to R variability analysis using the SFFECG produced results concordant to those using the surface ECG. CONCLUSION: SFFECG might be a helpful adjunct in implantable device systems for detection of R waves and may be used for measurement of R to R variability.

Water systems to report drinking water quality to all customers: how can health professionals prepare for the questions that these reports will generate?

The ultimate safety of drinking water depends upon protection of source waters and construction and maintenance of reliable drinking water treatment and distribution systems. These objectives require public support. Physicians can encourage their patients to call their water suppliers and advocate for investment in effective treatment systems and support zoning that will protect water supply watersheds and wellheads. The Consumer Confidence Reports are meant to inform consumers about their drinking water supply. Consumers should use the reports to verify that their drinking water meets all health standards and to understand some of the potential threats to their drinking water quality. Physicians may use the reports as an opportunity to discuss the many types of environmental exposures and ways to reduce these exposures. As a crucial component of the public health community, this is your opportunity to encourage your patients to become more aware of their environment and its impact on their health.

P wave and far-field R wave detection in pacemaker patient atrial electrograms.

This study was undertaken to develop and test a morphology-based adaptive algorithm for real-time detection of P waves and far-field R waves (FFRWs) in pacemaker patient atrial electrograms. Cardiac event discrimination in right atrial electrograms has been a problem resulting in improper atrial sensing in implantable devices; potentially requiring clinical evaluation and device reprogramming. A morphology-based adaptive algorithm was first evaluated with electrograms recorded from 25 dual chamber pacemaker implant patients. A digital signal processing (DSP) system was designed to implement the algorithm and test real-time detection. In the second phase, the DSP implementation was evaluated in 13 patients. Atrial and ventricular electrograms were processed in real-time following algorithm training performed in the first few seconds for each patient. Electrograms were later manually annotated for comparative analysis. The sensitivity for FFRW detection in the atrial electrogram during off-line analysis was 92.5% (+/- 10.9) and the positive predictive value was 99.1% (+/- 1.8). Real-time P wave detection using a DSP system had a sensitivity of 98.9% (+/- 1.3) and a positive predictivity of 97.3% (+/- 3.5). FFRW detection had a sensitivity of 91.0% (+/- 12.4) and a positive predictivity of 97.1% (+/- 4.2) in atrial electrograms. DSP algorithm tested can accurately detect both P waves and FFRWs in right atrium real-time. Advanced signal processing techniques can be applied to arrhythmia detection and may eventually improve detection, reduce clinician interventions, and improve unipolar and bipolar lead sensing.

Automatic and efficient R wave discrimination in the right atrium using a two-state hidden Markov model.

INTRODUCTION: Discrimination of far-field R waves from atrial events in atrial electrograms (EGMs) is problematic in present implantable pacing systems. Adjustments of atrial refractory periods and sensitivity settings are the only options, and they will not provide optimal performance in many patients. The reliable detection or rejection of R waves in atrial EGMs would avoid problems of atrial undersensing or oversensing, thus benefiting DDD patients by providing more reliable and specific atrial arrhythmia detection. In addition, detection of far-field R waves could allow a measurement of AV conduction time in AAI and aid in discrimination of supraventricular tachyarrhythmia from ventricular tachyarrhythmia. METHODS AND RESULTS: Both atrial and ventricular unipolar EGMs were collected from 25 patients undergoing pacemaker implant or replacement. An average of 141 seconds of intrinsic or VVI paced EGMs was recorded and post analyzed. A new two-state hidden Markov model (HMM) was developed specifically for far-field R wave and P wave discrimination in the atrium. The recorded patients' EGMs were analyzed using this model, and the sensitivity and positive predictivity of far-field R wave detection were evaluated. The collected atrial EGMs were visually examined and marked as the control for verification of the detection analysis. Far-field R wave detection using this model had an overall sensitivity of 94% +/- 9.4% and a positive predictivity of 98.3% +/- 4.4%; and the far-field R wave rejection using the same model had a sensitivity and a positive predictivity of 98.8% +/- 3.8% and 99.1% +/- 1.7%, respectively. CONCLUSION: Far-field R wave detection in the right atrium by the two-state HMM is reliable and accurate, and can significantly improve atrial arrhythmia management for patients.

The influence of sensor orientation on activity-based rate responsive pacing. Sensor Orientation Study Group.

Piezoelectric activity-based rate responsive pacemakers are commonly implanted with the sensor facing inward. This study was conducted to assess the safe and effective rate response of an activity-based rate responsive pacemaker implanted with the sensor facing outward. A comparison were made to a previously studied patient group with sensor facing inward. Patient and pacemaker data was collected at predischarge and 2-month follow-up. Two-minute hall walks in conjunction with programmer-assisted rate response assessment were utilized to standardize initial rate response parameter settings for both patient groups. At 2-month follow-up, sensor rate response to a stage 3 limited CAEP protocol was recorded. Adequate sensor rate response was achieved for both patient groups. No difference was noted in reported patient complications for both groups. A statistically significant difference in programmed rate response curve setting and activity threshold for the two groups was noted at 2-month follow-up. Adequate sensor rate response was achieved for a patient population implanted with an activity-based rate responsive pacemaker with sensor facing outward. In this orientation, one higher rate response curve setting and an activity threshold one value more sensitive were required on average when compared to the normal sensor orientation group.

A comparative study of activity and dual sensor: activity and minute ventilation pacing responses to ascending and descending stairs.

Previous studies with activity-based rate adaptive pacemakers have shown a somewhat paradoxical response when comparing ascending stairs to descending stairs. The objective of this investigation was to measure dual-sensor rate response provided by activity and minute ventilation (MV) compared with activity alone, and with a control group, during ascending and descending stairs. For dual sensor mode, measured mean peak pacing rate with 72 (92) steps per minute was 111 +/- 13 beats/min (124 +/- 14 beats/min) ascending stairs and 81 +/- 7 beats/min (97 +/- 13 beats/min) for descending. For activity mode alone, mean peak pacing rate was 90 +/- 12 beats/min (108 +/- 19 beats/min) ascending stairs and 97 +/- 12 beats/min (123 +/- 17 beats/min) descending. The mean peak control group heart rate ascending stairs for a step rate of 72 (92) steps/min were 116 +/- 11 beats/min (127 +/- 14 beats/min) ascending stairs and for descending 89 +/- 12 beats/min (95 +/- 11 beats/min). While for dual sensor controlled pacing there was a significant difference for ascending and descending stairs at both step rates, there was no difference between going upstairs and downstairs for activity mode alone. Rates with dual sensor did not significantly differ from respective rates of the control group. The mean correlation coefficient between MV and paced rate was 0.85. Pacing heart rates delivered by the dual sensor mode were appropriate for ascending and descending stairs. In contrast to activity mode alone, the peak heart rates for dual sensor mode are higher during ascending than during descending stairs.

Electrogram signals recorded from acute and chronic pacemaker implantation sites in pacemaker patients.

Electrogram signals recorded from typical pacemaker implantation sites may be useful for a variety of pacemaker system functions including pacemaker follow-up, atrial and ventricular sensing (event detection), and triggered electrogram storage. We quantified the electrical characteristics of pacemaker pocket electrograms using a subcutaneous electrode array (SEA) in a population of 48 patients undergoing initial or replacement pacemaker implantation. SEA recorded intrinsic R wave amplitudes measured peak to peak averaged 118 microV and 65 microV for the two recorded SEA electrograms and were significantly different (P < 0.001); paced R wave amplitudes averaged 180 microV and 110 microV. P wave amplitudes averaged 39 microV and 26 microV. No statistically significant difference in amplitudes were observed between acute versus chronic pacemaker pocket or indication for pacing (AV block, sick sinus syndrome). Signal to noise ratios, using R wave amplitude as signal, were lower in the SEA electrogram on average (11 dB) compared to the intracardiac electrogram (27 dB), but sufficient for diagnostic assessment. R wave/P wave ratios for SEA signals were lower than surface and intracardiac values 3.1 and 2.7 compared to a range of 6.2-9.8, indicating a relative enhancement of P waves to R waves in SEA signals. In summary, SEA electrograms are of sufficient amplitude and signal quality (signal to noise ratio) to hold promise for future implantable device features such as electrogram telemetry, enhanced sensing, and diagnostic data storage.

Eliminating bradyarrhythmias after orthotopic heart transplantation.

BACKGROUND: Bradycardia and sinus node dysfunction are common causes of early postoperative morbidity in orthotopic heart transplant recipients and frequently require the use of chronotropic drugs or permanent pacemakers. Several causes have been postulated, including surgical trauma to the sinus node and its blood supply. We sought to eliminate sinus node dysfunction and postoperative bradyarrhythmias by altering the orthotopic heart transplantation technique. METHODS AND RESULTS: Seventy orthotopic heart transplant recipients underwent electrophysiological testing of sinus node function a mean of 9 +/- 3 days after surgery. Standard (atrial anastomosis) orthotopic heart transplantation was performed in 33 patients; total (bicaval anastomosis) heart transplantation was performed in 37 patients. Abnormalities of sinus node function were present in 14 of 33 patients (42%) undergoing standard orthotopic heart transplantation compared with 2 of 37 patients arrhythmia (5%) in whom total heart transplantation was performed (P < .005). The resting sinus heart rate of patients with a normal sinus rhythm was also significantly higher in the total heart transplantation group (90 +/- 12 versus 83 +/- 14 bpm, P < .05). Coronary angiography was performed before discharge in 63 patients. Eleven were found to have an abnormal sinoatrial nodal artery, and 7 of these patients also had evidence of sinus node dysfunction (P < .005). CONCLUSIONS: Surgical trauma to the donor sinus node and/or its blood supply is a significant cause of sinus node dysfunction in the orthotopic heart transplant recipient. By use of a bicaval anastomotic technique, the incidence of and need for treatment of postoperative bradyarrhythmias can be significantly reduced.

Surgical clips as a nidus for biliary stone formation: diagnosis and therapy.

Two cases in which a cystic duct stump clip migrated into the common bile duct and formed the nidus for a stone are reported. In one case, the diagnosis was made before ERCP, on the basis of CT findings. In the second case, a retrospective review of plain abdominal films showed evidence of clip migration. Both patients were treated successfully with endoscopic sphincterotomy, as have most such patients reported in the literature. Although clip migration can occur after both open and laparoscopic cholecystectomy, there is some evidence that this complication may be more common after the laparoscopic procedure. Clip migration can be diagnosed before cholangiography by carefully reviewing plain abdominal films and CT scans. ERCP confirms the diagnosis, and sphincterotomy with clip and stone removal is the therapeutic procedure of choice. Additional surgical procedures only rarely are required.

Initial clinical experience with a new dual sensor SSIR pacemaker controlled by body activity and minute ventilation.

Fourteen patients were implanted with a single chamber dual sensor pacemaker (Legend Plus) that measures minute ventilation (VE) via variations in impedance between a bipolar lead and the pacemaker case, and activity via a piezoelectric crystal bonded to the pacemaker case. Chronotropic incompetent patients were exercised on a treadmill and a bicycle in dual sensor mode. Activity only indicated pacing rate was measured using a strap-on pacemaker. Both implanted and strap-on pacemakers were adjusted to yield a steady-state pacing rate of 100 beats/min during hall walk. Pacing rate, VE, and oxygen uptake (VO2) were measured continuously. Linear curve fit analysis slopes for plots of VE versus pacing rate during exercise (1.33-1.49) compared favorably to values reported in normals. Peak pacing rates achieved for treadmill and bicycle testing for dual sensor mode were higher than activity mode alone. Slopes of heart rate to VE or VO2 were not significantly different (P < 0.05) for dual sensor mode in contrast to activity alone. In conclusion, the Legend Plus dual sensor rate adaptive pacing therapy delivered pacing rates more proportional to VE and VO2 under different types of exercise than rates indicated by a strap-on pacemaker in activity mode.

Feasibility of an implantable arrhythmia monitor.

Conventional Holter monitoring is of limited benefit in patients with infrequent symptoms suspected to be related to arrhythmia. A small recorder implanted subcutaneously might obviate many limitations of conventional monitoring. To determine the feasibility of obtaining adequate electrocardiographic signals from such a device, a prototype was temporarily implanted in 17 patients undergoing pacemaker implantation. The prototype contained four disc-shaped titanium electrodes, 0.21 inches in diameter embedded in epoxy. The four electrodes were in a square configuration spaced 0.72 inches center to center and were placed face down in a subcutaneous pocket in the left pectoral region. Bipolar recordings were made from a horizontal pair, a vertical pair, and both diagonal paris of electrodes (interelectrode distance 1.02 inches) and recorded on electromagnetic tape after filtering at 0.5-250 Hz. The mean peak-to-peak amplitude in each configuration was determined over a five-beat interval. Clear recordings were obtained from all 17 patients with recognizable P, QRS, and T waves. The amplitude of the signals obtained from the diagonal pairs of electrodes (175 +/- 51 and 170 +/- 54 microV) were greater than obtained from either the vertical pair (142 +/- 62 microV, P = 0.08 compared to diagonal electrodes) or the horizontal pair of electrodes (105 +/- 54 microV, P < 0.01). The maximum amplitude recorded from any configuration was 189 +/- 54 microV. In six patients the device was also tested with the electrodes face up in the subcutaneous pocket.(ABSTRACT TRUNCATED AT 250 WORDS)

Feasibility of using intracardiac impedance measurements for capture detection.

Energy consumption and longevity of modern pacemakers are determined by the controlling electronic circuitry and by the stimulation energy. While with technological progress the electronics' energy consumption has been reduced significantly, clinical practice shows that many cardiac pacemakers are programmed to suboptimal settings with regard to minimization of pacing energy consumption. Several methods for optimizing pacemaker output settings have been proposed in the past. The most promising concept is an output parameter optimizing pacemaker with automatic capture detection. We examined whether it is possible to distinguish between effective and ineffective pacemaker stimulus capture by analyzing high pass filtered intracardiac impedance signals that are derived from standard bipolar pacing leads. In one series of 11 patients undergoing replacement or implantation of chronic bipolar pacemakers, four patients during electrophysiology studies, and eight volunteers undergoing invasive electrophysiology trials, we examined intracardiac impedance signals obtained with various stimulation rates and output parameter settings. Additionally we analyzed a series of five patients with implanted pacemakers that can measure and telemeter intracardiac impedance signals. Several evaluation concepts have been analyzed regarding their ability to discriminate between effective and ineffective stimuli. We developed an adequate algorithm that detects capture or loss of capture at different output parameter settings based on intracardiac impedance analysis. The sensitivity is 98.5% and specificity is 91% to loss of capture for the currently investigated algorithm and this can be used to determine the optimal setting of pulse width and amplitude with regard to energy consumption. This concept is currently under realization in the external programmer and in the future an implementation of these algorithms within the pacemaker itself is intended.