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Charanjit S Rihal - One of the best experts on this subject based on the ideXlab platform.

  • hemodynamic response to transseptal transcatheter mitral valve replacement in patients with severe mitral stenosis due to severe mitral annular calcification
    Catheterization and Cardiovascular Interventions, 2021
    Co-Authors: Naoki Misumida, Charanjit S Rihal, Mayra Guerrero, Sorin V Pislaru, Mohamad Alkhouli, Mackram F Eleid
    Abstract:

    Objectives We aimed to investigate the invasive hemodynamic changes with transcatheter mitral valve replacement (TMVR) in patients with severe mitral stenosis due to severe mitral annular calcification. Background The hemodynamic response to TMVR in patients with mitral stenosis related to degenerative mitral annular calcification has not been fully elucidated. Methods We conducted retrospective review of patients who underwent successful transseptal TMVR with balloon-expandable valves for symptomatic severe mitral stenosis due to mitral annular calcification at our institution between January 2014 and February 2020. Invasive hemodynamic measurements were obtained both before valve implantation (predeployment) and after (postdeployment). Results Eighteen patients (age 72 ± 10 years, 44% female) were included for the analysis. There was a significant reduction in mean Left Atrial Pressure (23.7 ± 5.6 mmHg versus 20.6 ± 4.8 mmHg; p = .01), Left Atrial v-wave (mean 39.3 ± 10.2 mmHg versus 32.9 ± 9.9 mmHg; p = .01), and an increase in systemic mean blood Pressure (72.6 mmHg ±11.2 versus 79.5 ± 9.9 mmHg; p = .02) postdeployment compared to predeployment. Patients who had symptom improvement at 30-day follow-up tended to have greater reduction in mean Left Atrial Pressure (4.4 ± 4.4 mmHg versus 0.5 ± 5.2 mmHg; p = .16) and v-wave (8.6 ± 9.0 mmHg versus 0.7 ± 8.4 mmHg; p = .10) compared to those who did not experience improvement of symptoms. Conclusions Transseptal TMVR for severe mitral stenosis due to mitral annular calcification is associated with reductions in mean Left Atrial Pressure and Left Atrial v-wave, and an increase in systemic arterial Pressure.

  • comparison of Left Atrial Pressure monitoring with dedicated catheter versus steerable guiding catheter during transcatheter mitral valve repair
    Catheterization and Cardiovascular Interventions, 2018
    Co-Authors: Mackram F Eleid, Guy S Reeder, Charanjit S Rihal
    Abstract:

    OBJECTIVE: The objective of this study was to determine the accuracy of Left Atrial Pressure (LAP) measurement through the manufacturer provided steerable guiding catheter (SGC) during transcatheter mitral valve repair (TMVR). BACKGROUND: LAP measurement during TMVR has been shown to be associated with clinical improvement when measured through a dedicated catheter. METHODS: Simultaneous LAP was performed in consecutive patients using an independent fluid-filled 4F multipurpose catheter and compared to LAP waveforms measured through the manufacturer-provided MitraClip SGC during TMVR (Abbott, Santa Clara, CA). RESULTS: Mean age of 10 consecutive subjects with primary mitral regurgitation undergoing TMVR was 83 ± 3 years (60% female). Left Atrial v wave and mean Pressures through the dedicated catheter were 42 ± 7 and 24 ± 3 mmHg vs. 35 ± 7 and 23 ± 3 mmHg through the SGC (P < 0.001 and P = 0.23, respectively). Mean differences in v wave and mean LAP were 8 ± 4 and 1.0 ± 2.4 mmHg (percent difference 19 and 3%), respectively. SGC waveform overdamping was observed in all cases. CONCLUSIONS: Left Atrial v wave Pressure measurement through a dedicated catheter with sideholes during TMVR has superior accuracy compared to the manufacturer provided SGC, which results in waveform overdamping and a significant underestimation of v wave Pressure. These data have important implications for clinical practice.

  • Left Atrial Pressure and predictors of survival after percutaneous mitral paravalvular leak closure
    Catheterization and Cardiovascular Interventions, 2017
    Co-Authors: Elad Maor, Mackram F Eleid, Guy S Reeder, Mohamad Alkhouli, Claire E Raphael, Sidakpal S Panaich, Allison K Cabalka, Donald J Hagler, Peter Pollak, Charanjit S Rihal
    Abstract:

    Background Data on the clinical utility of Left Atrial (LA) hemodynamic monitoring during percutaneous mitral interventions are limited. Objectives To evaluate the association between intraprocedural LA Pressures during percutaneous mitral paravalvular leak (PVL) closure and long term survival. Methods Patients who underwent mitral PVL repair with invasive LA Pressure monitoring were divided at baseline to three tertiles based on their mean final LA Pressure ( 30% of mean systolic blood Pressure). Primary outcome was all-cause mortality. Results 134 patients (mean age 68 ± 12 years) were studied. Over 3 year mean follow-up, 81 (38%) patients died. The cumulative probability of death at 3 years was significantly higher among patients in the highest LA Pressure tertile (56 ± 8% vs. 28 ± 5%, log rank P < 0.001). More than mild residual mitral regurgitation (MR) by transesophageal echocardiography (TEE) was associated with a 2.5-fold increased risk of death and patients in the highest LA Pressure tertile had 2.2-fold higher mortality (P < 0.001 and = 0.003 respectively). After adjustment for residual MR by TEE, each 10% acute procedural reduction in LA Pressures was associated with a significant 9% reduced risk of death (P = 0.023). Multivariate Cox regression with adjustment for multiple predictors of death showed that patients in lower LA Pressure tertiles had 59% lower mortality (P = 0.003). Conclusion Lower LA Pressure following mitral PVL closure is an independent predictor of improved survival, even after adjustment for residual MR. LA Pressure monitoring may be a useful tool for procedural guidance during mitral PVL closure.

  • continuous Left Atrial Pressure monitoring during mitraclip assessing the immediate hemodynamic response
    Jacc-cardiovascular Interventions, 2015
    Co-Authors: Mackram F Eleid, Saurabh Sanon, Guy S Reeder, Rakesh M Suri, Charanjit S Rihal
    Abstract:

    We describe the novel use of continuous Left Atrial Pressure (LAP) monitoring to guide the MitraClip (Abbott Vascular, Santa Clara, California) procedure. In addition to transesophageal echocardiography, we have found that direct measurement of LAP is also a useful tool to determine the hemodynamic

Mackram F Eleid - One of the best experts on this subject based on the ideXlab platform.

  • hemodynamic response to transseptal transcatheter mitral valve replacement in patients with severe mitral stenosis due to severe mitral annular calcification
    Catheterization and Cardiovascular Interventions, 2021
    Co-Authors: Naoki Misumida, Charanjit S Rihal, Mayra Guerrero, Sorin V Pislaru, Mohamad Alkhouli, Mackram F Eleid
    Abstract:

    Objectives We aimed to investigate the invasive hemodynamic changes with transcatheter mitral valve replacement (TMVR) in patients with severe mitral stenosis due to severe mitral annular calcification. Background The hemodynamic response to TMVR in patients with mitral stenosis related to degenerative mitral annular calcification has not been fully elucidated. Methods We conducted retrospective review of patients who underwent successful transseptal TMVR with balloon-expandable valves for symptomatic severe mitral stenosis due to mitral annular calcification at our institution between January 2014 and February 2020. Invasive hemodynamic measurements were obtained both before valve implantation (predeployment) and after (postdeployment). Results Eighteen patients (age 72 ± 10 years, 44% female) were included for the analysis. There was a significant reduction in mean Left Atrial Pressure (23.7 ± 5.6 mmHg versus 20.6 ± 4.8 mmHg; p = .01), Left Atrial v-wave (mean 39.3 ± 10.2 mmHg versus 32.9 ± 9.9 mmHg; p = .01), and an increase in systemic mean blood Pressure (72.6 mmHg ±11.2 versus 79.5 ± 9.9 mmHg; p = .02) postdeployment compared to predeployment. Patients who had symptom improvement at 30-day follow-up tended to have greater reduction in mean Left Atrial Pressure (4.4 ± 4.4 mmHg versus 0.5 ± 5.2 mmHg; p = .16) and v-wave (8.6 ± 9.0 mmHg versus 0.7 ± 8.4 mmHg; p = .10) compared to those who did not experience improvement of symptoms. Conclusions Transseptal TMVR for severe mitral stenosis due to mitral annular calcification is associated with reductions in mean Left Atrial Pressure and Left Atrial v-wave, and an increase in systemic arterial Pressure.

  • comparison of Left Atrial Pressure monitoring with dedicated catheter versus steerable guiding catheter during transcatheter mitral valve repair
    Catheterization and Cardiovascular Interventions, 2018
    Co-Authors: Mackram F Eleid, Guy S Reeder, Charanjit S Rihal
    Abstract:

    OBJECTIVE: The objective of this study was to determine the accuracy of Left Atrial Pressure (LAP) measurement through the manufacturer provided steerable guiding catheter (SGC) during transcatheter mitral valve repair (TMVR). BACKGROUND: LAP measurement during TMVR has been shown to be associated with clinical improvement when measured through a dedicated catheter. METHODS: Simultaneous LAP was performed in consecutive patients using an independent fluid-filled 4F multipurpose catheter and compared to LAP waveforms measured through the manufacturer-provided MitraClip SGC during TMVR (Abbott, Santa Clara, CA). RESULTS: Mean age of 10 consecutive subjects with primary mitral regurgitation undergoing TMVR was 83 ± 3 years (60% female). Left Atrial v wave and mean Pressures through the dedicated catheter were 42 ± 7 and 24 ± 3 mmHg vs. 35 ± 7 and 23 ± 3 mmHg through the SGC (P < 0.001 and P = 0.23, respectively). Mean differences in v wave and mean LAP were 8 ± 4 and 1.0 ± 2.4 mmHg (percent difference 19 and 3%), respectively. SGC waveform overdamping was observed in all cases. CONCLUSIONS: Left Atrial v wave Pressure measurement through a dedicated catheter with sideholes during TMVR has superior accuracy compared to the manufacturer provided SGC, which results in waveform overdamping and a significant underestimation of v wave Pressure. These data have important implications for clinical practice.

  • Left Atrial Pressure and predictors of survival after percutaneous mitral paravalvular leak closure
    Catheterization and Cardiovascular Interventions, 2017
    Co-Authors: Elad Maor, Mackram F Eleid, Guy S Reeder, Mohamad Alkhouli, Claire E Raphael, Sidakpal S Panaich, Allison K Cabalka, Donald J Hagler, Peter Pollak, Charanjit S Rihal
    Abstract:

    Background Data on the clinical utility of Left Atrial (LA) hemodynamic monitoring during percutaneous mitral interventions are limited. Objectives To evaluate the association between intraprocedural LA Pressures during percutaneous mitral paravalvular leak (PVL) closure and long term survival. Methods Patients who underwent mitral PVL repair with invasive LA Pressure monitoring were divided at baseline to three tertiles based on their mean final LA Pressure ( 30% of mean systolic blood Pressure). Primary outcome was all-cause mortality. Results 134 patients (mean age 68 ± 12 years) were studied. Over 3 year mean follow-up, 81 (38%) patients died. The cumulative probability of death at 3 years was significantly higher among patients in the highest LA Pressure tertile (56 ± 8% vs. 28 ± 5%, log rank P < 0.001). More than mild residual mitral regurgitation (MR) by transesophageal echocardiography (TEE) was associated with a 2.5-fold increased risk of death and patients in the highest LA Pressure tertile had 2.2-fold higher mortality (P < 0.001 and = 0.003 respectively). After adjustment for residual MR by TEE, each 10% acute procedural reduction in LA Pressures was associated with a significant 9% reduced risk of death (P = 0.023). Multivariate Cox regression with adjustment for multiple predictors of death showed that patients in lower LA Pressure tertiles had 59% lower mortality (P = 0.003). Conclusion Lower LA Pressure following mitral PVL closure is an independent predictor of improved survival, even after adjustment for residual MR. LA Pressure monitoring may be a useful tool for procedural guidance during mitral PVL closure.

  • continuous Left Atrial Pressure monitoring during mitraclip assessing the immediate hemodynamic response
    Jacc-cardiovascular Interventions, 2015
    Co-Authors: Mackram F Eleid, Saurabh Sanon, Guy S Reeder, Rakesh M Suri, Charanjit S Rihal
    Abstract:

    We describe the novel use of continuous Left Atrial Pressure (LAP) monitoring to guide the MitraClip (Abbott Vascular, Santa Clara, California) procedure. In addition to transesophageal echocardiography, we have found that direct measurement of LAP is also a useful tool to determine the hemodynamic

David M Kaye - One of the best experts on this subject based on the ideXlab platform.

  • transcatheter interAtrial shunt device for the treatment of heart failure with preserved ejection fraction reduce lap hf i reduce elevated Left Atrial Pressure in patients with heart failure a phase 2 randomized sham controlled trial
    Circulation, 2018
    Co-Authors: Ted Feldman, David M Kaye, Laura Mauri, Rami Kahwash, Sheldon E Litwin, Mark J Ricciardi, Pim Van Der Harst, Martin Penicka, Peter S Fail, Mark C Petrie
    Abstract:

    Background: In nonrandomized, open-label studies, a transcatheter interAtrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge Pressure (PCWP), fewer symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and midrange or preserved ejection fraction (EF ≥40%). We conducted the first randomized sham-controlled trial to evaluate the IASD in HF with EF ≥40%. Methods: REDUCE LAP-HF I (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association class III or ambulatory class IV HF, EF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right Atrial Pressure gradient ≥5 mm Hg. Participants were randomized (1:1) to the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness end point was exercise PCWP at 1 month. The primary safety end point was major adverse cardiac, cerebrovascular, and renal events at 1 month. PCWP during exercise was compared between treatment groups using a mixed-effects repeated measures model analysis of covariance that included data from all available stages of exercise. Results: A total of 94 patients were enrolled, of whom 44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years, and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared with sham control ( P =0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mm Hg in the treatment group versus 0.5±5.0 mm Hg in the control group ( P =0.14). There were no peri-procedural or 1-month major adverse cardiac, cerebrovascular, and renal events in the IASD group and 1 event (worsening renal function) in the control group ( P =1.0). Conclusions: In patients with HF and EF ≥40%, IASD treatment reduces PCWP during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation. Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT02600234.

  • one year outcomes after transcatheter insertion of an interAtrial shunt device for the management of heart failure with preserved ejection fraction
    Circulation-heart Failure, 2016
    Co-Authors: David M Kaye, Robert N Doughty, Petr Neuzil, Martin Penicka, Gerd Hasenfus, Martijn Post, Jeannoel Trochu, Adam Kolodziej, Ralf Westenfeld, Mark Rosenberg
    Abstract:

    Background—Heart failure with preserved ejection fraction has a complex pathophysiology and remains a therapeutic challenge. Elevated Left Atrial Pressure, particularly during exercise, is a key co...

  • transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interAtrial implant to lower Left Atrial Pressure
    European Journal of Heart Failure, 2014
    Co-Authors: Lars Sondergaard, Vivek Y Reddy, David M Kaye, Filip Malek, Antony Walton, Martin Mates, Olaf Franzen, Petr Neuzil, Nikolaj Ihlemann, Finn Gustafsson
    Abstract:

    Background Heart failure with preserved or mildly reduced ejection fraction (HFpEF) is common and, to date, therapeutic options are limited. Increased Left Atrial Pressure is a key contributor to the symptoms associated with HFpEF, particularly during physical activity. We report the 30-day outcome of patients treated with a novel device intended to lower Left Atrial Pressure by creating an 8 mm permanent shunt in the Atrial septum. Methods and results Eleven patients were enrolled in the pilot trial. Key inclusion criteria were: EF >45%; baseline PCWP ≥15 mmHg (rest), or ≥ 25 mmHg (exercise); and ≥1 hospitalization for heart failure within the past 12 months, or persistent NYHA class III/IV for at least 3 months. Mean age, LVEF, and NYHA class were 70 ± 12 years, 57 ± 9%, and 3.2 ± 0.4, respectively. Most patients had significant co-morbidities. The interAtrial septal device (IASD) device was implanted using percutaneous trans-septal access via the femoral vein. The device was successfully implanted in all patients. At 30 days, LV filling Pressures were significantly reduced by 5.5 mmHg (19.7 ± 3.4 vs. 14.2 ± 2.7; P = 0.005), and NYHA class was improved by two classes in two patients, one class in five patients, and worsened by one class in one patient. No patient developed pulmonary hypertension. Two serious adverse events occurred; heart failure re-hospitalization, and implant malposition successfully treated with a new device. Conclusion Contemporary management of HFpEF patients is confounded by the lack of effective therapies. The use of a device-based approach to reduce Left Atrial Pressure provides a novel means to improve haemodynamic and symptomatic status in HFpEF patients and warrants further investigation.

  • tct 136 results of a novel interAtrial shunt therapy for heart failure and preserved or mildly reduced ejection fraction
    Journal of the American College of Cardiology, 2013
    Co-Authors: Finn Gustafsson, Lars Sondergaard, Vivek Y Reddy, Filip Malek, Petr Neuzil, Tony Walton, David M Kaye
    Abstract:

    Diastolic dysfunction develops in most cardiac conditions, and leads to elevation of Left ventricular filling Pressures and heart failure. We report the initial experience with a novel device intended to lower Left Atrial Pressure by creating a small permanent Atrial septal shunt. The objective of

Aristomenis Manouras - One of the best experts on this subject based on the ideXlab platform.

  • Left Atrial Pressure pulsatility attenuates pulmonary vascular compliance in heart failure
    Journal of Heart and Lung Transplantation, 2020
    Co-Authors: Emil Najjar, Camilla Hage, Lars Lund, Jonas Johnson, Aristomenis Manouras
    Abstract:

    Purpose It has been demonstrated that elevations in mean pulmonary artery wedge Pressure (PAWPm) yield a Leftward and downward shift of the pulmonary arterial compliance (PAC)-pulmonary vascular resistance (PVR) hyperbolic curve suggesting that higher PAWPm augments RV pulsatile relative to resistive load and may contribute to RV dysfunction. However, the PAWPm comprises an integration of both the steady and the pulsatile Pressure occurring during the heart circle. In the current study we sought to address the differential impact of the steady and pulsatile components of PAWPm on the PAC-PVR relationship. Methods The study population consisted of 192 patients with hemodynamic findings indicating heart failure (HF) defined as elevated PAWPm at rest or during exercise. Figure 1 illustrates the method used to measure the steady and pulsatile components of PAWPm. Results The PAC and PVR were hyperbolically and inversely associated and the subgroup of patients with PAWPm above the median (18 mmHg) showcased a shift of the curve fit downwards and to the Left. As illustrated in Figure 2a and 2b, the group of patients with steady PAWP (PAWPs) above the median (16.7 mmHg) demonstrated a slight shift of the PAC-PVR fit curve downwards and to the Left. On the other hand, there was a clear downward and Leftward shift of the PVR-PAC curve fit for the patient cohort with higher pulsatile PAWP (PAWPp) component (3.5 mmHg). Conclusion Higher pulsatile rather than steady PAWP component changes significantly the PVR-PAC relationship in patients with HF.

  • the pulmonary capillary wedge Pressure accurately reflects both normal and elevated Left Atrial Pressure
    European Heart Journal, 2014
    Co-Authors: A I Nagy, Ashwin I Venkatesharan, Bela Merkely, Reidar Winter, B Barooah, P K Dash, Aristomenis Manouras
    Abstract:

    The pulmonary capillary wedge Pressure accurately reflects both normal and elevated Left Atrial Pressure

Jay Ritzema - One of the best experts on this subject based on the ideXlab platform.

  • serial doppler echocardiography and tissue doppler imaging in the detection of elevated directly measured Left Atrial Pressure in ambulant subjects with chronic heart failure
    Jacc-cardiovascular Imaging, 2011
    Co-Authors: Jay Ritzema, Neal L Eigler, Iain Melton, Ian Crozier, Robert N Doughty, Mark A Richards, Christopher F Frampton, J Stewart, James S. Whiting
    Abstract:

    Objectives This study sought to determine the accuracy of Doppler echocardiography and tissue Doppler imaging (TDI) measurements in detecting elevated Left Atrial Pressure (LAP) in ambulant subjects with chronic heart failure using directly measured LAP as the reference. Background Echocardiographic indexes including the ratio of transmitral to annular early diastolic velocities (E/e′) may identify raised invasively measured Left ventricular filling Pressures when tested in cross-sectional studies in some populations. The accuracy of these indexes when measured sequentially remains untested. We determined the accuracy of Doppler echocardiography and TDI measurements in detecting elevated directly measured LAP in ambulant subjects with stable chronic heart failure. Methods Fifteen patients with New York Heart Association functional class II to III heart failure and a permanently implanted direct LAP monitoring device underwent serial echocardiography. Simultaneous resting mean LAP, Doppler mitral inflow, mitral annular TDI, and pulmonary venous inflow velocities were obtained on each occasion. Receiver-operator characteristic curve analysis was used to compare the accuracy of the Doppler variables to detect an elevated device LAP ≥15 and ≥20 mm Hg. Results The patients (13 men, mean age: 71 years, mean Left ventricular ejection fraction: 32 ± 12%) underwent 60 simultaneous echocardiographic studies and LAP measurements with a median of 4 (1 to 7) studies per patient. Mean LAP was 16.9 (range 5 to 39 mm Hg) at echocardiography (n = 60). E/e′ had the greatest accuracy for detection of LAP ≥15 mm Hg with an area beneath the receiver-operator characteristic curve >0.9. In comparison, area under the curve for mitral E velocity and mitral E/A were 0.77 and 0.76, respectively (p Conclusions Single and serial measurements of mitral inflow and mitral annular TDI velocities (E/e′) can reliably detect raised directly measured LAP in ambulant subjects with compensated chronic heart failure. (Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients [HOMEOSTASIS]; NCT00547729 )

  • Direct Left Atrial Pressure Monitoring in Severe Heart Failure: Long-Term Sensor Performance
    Journal of Cardiovascular Translational Research, 2011
    Co-Authors: Richard W Troughton, Philip B Adamson, Neal L Eigler, Saibal Kar, Jay Ritzema, Henry Krum, Prediman K Shah, Iain C. Melton, James S. Whiting, J. Thomas Heywood
    Abstract:

    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
    Circulation, 2010
    Co-Authors: Jay Ritzema, Philip B Adamson, Saibal Kar, Richard W Troughton, Iain Melton, Ian Crozier, Robert N Doughty, Henry Krum, A Walton, Prediman K Shah
    Abstract:

    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 ...

  • direct Left Atrial Pressure monitoring in ambulatory heart failure patients initial experience with a new permanent implantable device
    Circulation, 2007
    Co-Authors: Jay Ritzema, Neal L Eigler, Saibal Kar, Iain Melton, Robert N Doughty, James S. Whiting, Mark A Richards, Ian G Crozier, Chris Frampton, Henry Krum
    Abstract:

    Background— We describe the first human experience with a permanently implantable, direct Left Atrial Pressure (LAP) monitoring system in ambulatory patients with chronic heart failure. Methods and Results— Eight patients with established heart failure and at least 1 heart failure hospitalization or unplanned visit for parenteral therapy in the last year underwent device implantation under fluoroscopic guidance. All subjects received aspirin 150 mg and clopidogrel 75 mg daily. Subjects measured LAP twice daily and attended a clinic regularly for data upload and device calibration. Right heart catheterization was performed at the time of device implantation and at 12 weeks. The device was implanted in all subjects with no procedural complications. At the 12-week follow-up, 87% of device LAP measurements were within ±5 mm Hg of simultaneous pulmonary capillary wedge Pressure readings over a wide range of Pressures (1.6 to 71 mm Hg). Net drift corrected by calibration was −0.2±1.9 mm Hg/mo. During short-term...