http://www.synergyhealthconcepts.com Synergy Health Concepts - Worldiwde Leader in CCSVI Diagnosis and Treatment Mon, 16 Jun 2014 03:28:41 +0000 en-US hourly 1 http://wordpress.org/?v=3.8.3 New TVAM Study Published in Journal of Endovascular Therapy http://www.synergyhealthconcepts.com/new-tvam-study-published-in-journal-of-endovascular-therapy/ http://www.synergyhealthconcepts.com/new-tvam-study-published-in-journal-of-endovascular-therapy/#comments Wed, 11 Jun 2014 19:07:55 +0000 http://www.synergyhealthconcepts.com/?p=3606 A new study on Transvascular Autonomic Modulation (TVAM) was published in the June 2014 edition of the Journal of Endovascular Therapy. The study compares the efficacy of the TVAM procedure vs. traditional balloon angioplasty in improving cardiovascular autonomic nervous system (ANS) dysfunction in Multiple Sclerosis (MS) patients. Readthe full study here: http://jevt.org/doi/full/10.1583/13-4605MR.1 Transvascular Autonomic Modulation: […]

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journal of endovascular therapy june 2014 cover

A new study on Transvascular Autonomic Modulation (TVAM) was published in the June 2014 edition of the Journal of Endovascular Therapy.

The study compares the efficacy of the TVAM procedure vs. traditional balloon angioplasty in improving cardiovascular autonomic nervous system (ANS) dysfunction in Multiple Sclerosis (MS) patients.

Readthe full study here: http://jevt.org/doi/full/10.1583/13-4605MR.1


Transvascular Autonomic Modulation: A Modified Balloon Angioplasty Technique for the Treatment of Autonomic Dysfunction in Multiple Sclerosis Patients

Authors: Michael Arata, MD, and Zohara Sternberg, PhD
Institution: Synergy Health Concepts, Newport Beach, CA, USA

Purpose

To describe the use of transvascular autonomic modulation (TVAM) to improve cardiovascular autonomic nervous system (ANS) dysfunction in multiple sclerosis (MS) patients, comparing the safety and efficacy of this modified technique with traditional balloon angioplasty.

Methods

Twenty-one MS patients (11 men; mean age 48.7±13.0 years) who presented with symptoms of cardiovascular ANS dysfunction underwent TVAM. These patients were compared with age/sex-matched MS patients (10 men; 49.3±11.1 years) in the same stages of the disease who presented with chronic cerebrospinal venous insufficiency (CCSVI) and who underwent venous balloon angioplasty. TVAM involved the coupling of balloon angioplasty of the internal jugular veins with the application of external manual compression and dilation of the azygos and renal veins; unlike traditional angioplasty for CCSVI, which treats only abnormal veins (≥50% stenosis or static valve), all targeted vessels were treated with TVAM regardless of the presence of an abnormality. The effect of TVAM on ANS function was indicated by determining heart rate variability based on the electrocardiographic R-R interval lengths using vector analysis to derive the mean circular resultant (MCR) and the expiration/inspiration (E/I) ratio, the Valsalva ratio, and the 30:15 postural ratio at 24 hours after intervention.

Results

Left renal vein compression was common among the TVAM patients and resulted in ≥50% luminal compromise in 10 of 21 patients. Azygos vein abnormalities (a static valve) were identified in 5 patients. Overall, 18 patients met the diagnostic criteria for CCSVI with at least one lesion >50%, but only 10 lesions were considered treatable by traditional balloon angioplasty. After intervention, the R-R interval values, including the 30:15 postural ratio (p=0.01), the MCR (p=0.1), and E/I ratio (p=0.1), were higher for the TVAM patients compared to the control group. The safety profile of the TVAM procedure was similar to that of traditional balloon angioplasty.

Conclusion

The combination of balloon angioplasty of anatomically normal veins coupled with external compression during dilation of these veins can improve indicators of ANS dysfunction. The safety and efficacy of TVAM in MS patients observed in this pilot study is encouraging, paving the way for the treatment of dysautonomia in pathological states other than MS. Further studies should investigate TVAM in a larger MS cohort.


Read the full study here: http://jevt.org/doi/full/10.1583/13-4605MR.1

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QSART Assessment of Venous Autonomic Modulation http://www.synergyhealthconcepts.com/qsart-assessment-of-transvascular-autonomic-modulation/ http://www.synergyhealthconcepts.com/qsart-assessment-of-transvascular-autonomic-modulation/#comments Sun, 08 Jun 2014 03:10:32 +0000 http://www.synergyhealthconcepts.com/?p=3599 QSART Assessment of Venous Autonomic Modulation Authors: Arata M., Debarge P. Institution: Synergy Health Concepts, Newport Beach, CA, USA Background Diagnostic tests used to assess autonomic nervous system (ANS) function such as heart rate variability (HRV) have been applied in MS and track with physical disability and disease progression. Sympathetic activity in particular correlates with […]

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QSART Assessment of Venous Autonomic Modulation

Authors: Arata M., Debarge P.
Institution: Synergy Health Concepts, Newport Beach, CA, USA

Background

Diagnostic tests used to assess autonomic nervous system (ANS) function such as heart rate variability (HRV) have been applied in MS and track with physical disability and disease progression. Sympathetic activity in particular correlates with MS disease activity which can be assessed by sudomotor testing. It has recently been shown that venous balloon dilation improves ANS function in multiple sclerosis (MS) patients. This effect is hypothesized to result from balloon stimulation of the venous distension reflex (VDR) leading to increased sympathetic tone. The objective of this study was to evaluate sudomotor for sympathetic assessment following venous balloon dilation.

Methods

Seventeen MS patients (12 women and 5 men), aged 34–79 years (mean = 51), with sudomotor confirmed sympathetic autonomic dysfunction underwent venous balloon dilation therapy. All procedures were performed at an outpatient vascular center with light sedation. Bilateral internal jugular, azygous, and left renal vein dilation was performed. Noncompliant balloons were used to result in vessel over-dilation of 10-20%. Jugular and azygos dilation was at the valvular level as depicted by IVUS. The left renal vein was dilated at site of maximal compression or one cm from the confluence of the renal vein and the inferior vena cava in the absence of compression. Inclusion criteria was ability to cannulate and exclusion criteria was the presence of acute thrombus.

Results

All seventeen procedures were completed successfully without acute adverse events in an outpatient center. Sudomotor testing demonstrated improved an increase in sweat volume at the foot from 0.180 to 0.295, Wilcoxon signed rank test (p=0.02) following treatment.

Conclusions

The results demonstrate statistically significant improvement in sympathetic tone in MS patients following venous balloon dilation. This is consistent with previous reports of improvements in BP and the postural component of HRV tests, which also represent alterations of sympathetic tone, following venous balloon treatment. The effect upon the sympathetic system by venous dilation is thought to represent activation of the venous distension reflex. Procedural improvement of autonomic dysfunction may have implications for treating other autonomic conditions. Further investigation is encouraged.

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Study Investigates Safety and Efficacy of TVAM Procedure http://www.synergyhealthconcepts.com/study-investigates-safety-efficacy-tvam-procedure/ http://www.synergyhealthconcepts.com/study-investigates-safety-efficacy-tvam-procedure/#comments Thu, 29 May 2014 20:58:41 +0000 http://www.synergyhealthconcepts.com/?p=3587 A new study on TVAM (transvascular autonomic modulation) was published in the April 2014 edition of ACTA PHLEBOLOGICA (Edizioni Minerva Medica), a Journal on Phlebology. The study investigates the safety and efficacy of the TVAM procedure. Download the full study here: http://www.minervamedica.it/en/journals/acta-phlebologica/article.php?cod=R43Y2014N01A0019 Transvascular Autonomic Modulation, Initial Assessment of Safety Authors: Arata M., Debarge P. Institution: […]

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edizioni-minerva-medica

A new study on TVAM (transvascular autonomic modulation) was published in the April 2014 edition of ACTA PHLEBOLOGICA (Edizioni Minerva Medica), a Journal on Phlebology. The study investigates the safety and efficacy of the TVAM procedure.

Download the full study here: http://www.minervamedica.it/en/journals/acta-phlebologica/article.php?cod=R43Y2014N01A0019


Transvascular Autonomic Modulation, Initial Assessment of Safety

Authors: Arata M., Debarge P.
Institution: Synergy Health Concepts, Newport Beach, CA, USA

Aim

This study assesses the safety of transvascular autonomic modulation (TVAM), a novel treatment for improving cardiovascular autonomic nervous system (ANS) dysfunction.

Methods

One hundred forty-four patients who exhibited symptoms of cardiovascular ANS dysfunction underwent TVAM. Treatment deviated from balloon angioplasty by treating veins (internal jugular, azygos and renal veins) regardless of the presence of vascular abnormalities. The improvement in ANS function was indicated by determining the changes in R-R interval during deep breathing, valsalva maneuver, and postural change.

Results

One hundred forty patients (97%) reported subjective improvement in at least one symptom. Warming of the extremities was seen in 64% of patients with improvements in fatigue, 62%, and cognition, 64%, also reported. Post treatment HRV analysis demonstrated MCR and postural response in 71% and 57%, respectively. The MCR parameter change reached statistical significance 0.75±2.1, P<0.01. Acute adverse events did not occur during any of the procedures. Two access site infections requiring oral antibiotic therapy and one jugular thrombosis were identified within 30 days of procedure, corresponding to an overall 30 day adverse event rate of 2.3%.

Discussion

TVAM appears safe to perform in the outpatient setting. Subjective symptomatic and HRV improvements are encouraging. TVAM should be investigated further.


Download the full study here: http://www.minervamedica.it/en/journals/acta-phlebologica/article.php?cod=R43Y2014N01A0019

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Transvascular Autonomic Modulation: Novel Venous Therapy For Autonomic Dysfunction http://www.synergyhealthconcepts.com/transvascular-autonomic-modulation-novel-venous-therapy-for-autonomic-dysfunction/ http://www.synergyhealthconcepts.com/transvascular-autonomic-modulation-novel-venous-therapy-for-autonomic-dysfunction/#comments Tue, 18 Feb 2014 20:59:41 +0000 http://www.synergyhealthconcepts.com/?p=3486 Authors: M. Arata, Z. Sternberg Institution: Synergy Health Concepts, Newport Beach, CA Background Chronic cerebrospinal venous insufficiency (CCSVI) has been described as a condition resulting from impaired CNS venous drainage. Venous balloon angioplasty (BA) has been performed as a treatment for CCSVI. Autonomic nervous system (ANS) dysfunction has been proposed as mechanism underlying the occurrence […]

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Authors: M. Arata, Z. Sternberg
Institution: Synergy Health Concepts, Newport Beach, CA

Background

Chronic cerebrospinal venous insufficiency (CCSVI) has been described as a condition resulting from impaired CNS venous drainage. Venous balloon angioplasty (BA) has been performed as a treatment for CCSVI. Autonomic nervous system (ANS) dysfunction has been proposed as mechanism underlying the occurrence of CCSVI. We hypothesize that the BA effect on clinical parameters is mediated by mechanical stimulation of perivascular autonomic fibers and is independent of vascular obstruction. The purpose of this study is to describe Trans-Vascular Autonomic Modulation (TVAM) in multiple sclerosis (MS) patients as a means of improving ANS dysfunction, comparing its safety and efficacy to the traditional BA.

Methods

Twenty-one MS patients who presented with symptoms of cardiovascular ANS dysfunction underwent TVAM. These patients were compared with twenty MS patients who presented with CSSVI, and who underwent traditional BA.

TVAM deviated from traditional BA in that target veins, bilateral internal jugular, azygos and left renal veins, were each dilated regardless of the presence of vascular abnormalities. This also included treatment of patients without evidence of abnormality in any of the target veins, eliminating the possibility of vascular effect. The improvement in cardiovascular ANS function was indicated by determining R-R interval variations during deep breathing (MCR, E/I ratio), valsalva maneuver (valsalva ratio), and postural changes (30:15 postural ratio).

Results

The safety profile of the TVAM procedure was similar to that of the traditional BA with no adverse events occurring in either group. However, TVAM increased MCR, E/I ratio, and postural ratio more significantly than the traditional BA. Post-intervention, improvements were seen in the TVAM group relative to baseline for MCR (3.34±0.41 vs. 2.44±0.48, 36.4%, P = 0.08), E/I ratio (1.11±0.01 vs. 1.09±0.01, 1.8%, P = 0.3), valsalva ratio (1.95±0.09vs. 1.74±0.09, 12%, P = 0.10) and postural ratio (1.36±0.08 vs. 1.04±0.09, 30.7%, P = 0.027).

The postural ratio response in the TVAM group relative to baseline (1.36±0.08 vs. 1.04±0.09, 30.7%, P = 0.027) demonstrated the largest change relative to post-intervention postural ratio in the control group (1.36±0.08vs. 1.167±0.03, 16.5 %, P = 0.016).

Conclusion

TVAM mediated deposition of mechanical energy to central veins by balloon dilation, including anatomically normal veins, can improve indicators of ANS dysfunction. The observed safety and efficacy of TVAM is encouraging, paving the way for the treatment of ANS dysfunction in pathological states other than MS. Further studies should investigate the response to TVAM in larger cohort.

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Venous Transvascular Autonomic Modulation (TVAM), Initial Assessment and Safety http://www.synergyhealthconcepts.com/venous-transvascular-autonomic-modulation-initial-assessment-and-safety/ http://www.synergyhealthconcepts.com/venous-transvascular-autonomic-modulation-initial-assessment-and-safety/#comments Fri, 07 Feb 2014 22:14:18 +0000 http://www.synergyhealthconcepts.com/?p=3466 Authors: Michael A. Arata, M.D. Institution: Synergy Health Concepts, Newport Beach, CA Background Patients undergoing central venous angioplasty (CVA) have demonstrated improvement in autonomic parameters. We hypothesize that this results from stimulation of low pressure baroreceptors during balloon inflation. This report describes the assessment of the autonomic effect of CVA using HRV parameters. Further, the […]

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Authors: Michael A. Arata, M.D.
Institution: Synergy Health Concepts, Newport Beach, CA

Background

Patients undergoing central venous angioplasty (CVA) have demonstrated improvement in autonomic parameters. We hypothesize that this results from stimulation of low pressure baroreceptors during balloon inflation. This report describes the assessment of the autonomic effect of CVA using HRV parameters. Further, the veins were treated independent of anatomic abnormality deviating from conventional angioplasty. Herein we detail the safety of this approach.

Methods

131 patients exhibiting symptoms of autonomic dysfunction were treated and assessed by HRV analysis. Dilation of each central vein (internal jugular, azygos and renal veins) occurred regardless of the presence of vascular abnormalities. The treatment’s objective was to dilate 10-25% beyond vessel area, as determined by intravascular ultrasound. The effect upon ANS function was indicated by HRV parameters as the outcomes of interest. Data are presented as mean ± sd. The distribution of each parameter was checked for normality. The before and after measurements of each parameter were compared using pair t-test for normal distribution and Wilcoxon signed rank test for skewed distribution. All statistical testing was performed at a two-sided 5% level of significance and used Statistical Analysis System version 9.3 software (SAS Institute, Cary, NC).

Results

The CVA procedure was successfully completed in all cases (technical success 100%). Post-treatment HRV analysis demonstrated an objective response by increases in MCR, E/I and postural components, MCR reaching statistical significance of 0.75±2.1, P <0.01 (Table 1). Acute adverse events did not occur during any of the procedures (0.0% acute adverse events).

Conclusion

The autonomic effect of CVA was demonstrated by HRV analysis. CVA with dilation of vessel independent of morphology appears safe. Validation and elucidation of the treatment effect is warranted, in light of the lack of definitive treatment options for autonomic dysfunction patients.

Table 1

HRV Parameters

Preprocedure (mean±std)

Postprocedure (mean±std)

HRV change (mean±std) with P value

MCR 2.23 2.99  0.75±2.1, P <0.01†
E/I 1.09 1.10  0.75±2.1, P 0.38*
Valsalva 1.77 1.70  -0.08±0.57, P 0.13†
Standing 1.56 1.64  0.09±3.25, P 0.1*

† Paired T-Test
*Wilcoxon Signed Rank Test

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Alterations in Hypothalamic Pituitary Adrenal Axis Following Central Venous Balloon Dilation http://www.synergyhealthconcepts.com/alterations-in-hypothalamic-pituitary-adrenal-axis-following-central-venous-balloon-dilation/ http://www.synergyhealthconcepts.com/alterations-in-hypothalamic-pituitary-adrenal-axis-following-central-venous-balloon-dilation/#comments Mon, 20 Jan 2014 15:46:33 +0000 http://www.synergyhealthconcepts.com/?p=3452 Authors: Michael A. Arata, M.D., Zohara Sternberg, Ph.D., Steven Cen, Ph.D. Institution: Synergy Health Concepts, Newport Beach, CA Purpose Chronic cerebrospinal venous insufficiency (CCSVI) has been described as a condition resulting from impaired CNS venous drainage in multiple sclerosis (MS) patients. Venous balloon angioplasty (BA) has been performed as a treatment for CCSVI, although a […]

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Authors: Michael A. Arata, M.D., Zohara Sternberg, Ph.D., Steven Cen, Ph.D.
Institution: Synergy Health Concepts, Newport Beach, CA

Purpose

Chronic cerebrospinal venous insufficiency (CCSVI) has been described as a condition resulting from impaired CNS venous drainage in multiple sclerosis (MS) patients. Venous balloon angioplasty (BA) has been performed as a treatment for CCSVI, although a direct link between venous obstruction and CCSVI has not been conclusively demonstrated. In addition, the dysfunction of hypothalamus pituitary adrenal (HPA) axis has been reported in MS patients, correlating with disease activity. Although MS patients undergoing treatment of CCSVI report improvements in quality life, the effect of this intervention on the HPA axis is unknown. The purpose of this study was to determine whether BA induces alterations in the HPA axis, indicated by changes in levels of ACTH and Cortisol.

Material and Methods

Eighty-eight patients underwent treatment of central venous BA for CCSVI correction. Serum samples were taken at baseline and 30 minutes after the completion of the procedure. ACTH and Cortisol were measured using electrochemiluminescence immunoassay. The change in serum ACTH and Cortisol levels was assessed using Wilcoxon signed rank test to determine whether the median differed from 0 using 2-sided test with the α level of 0.05. All statistical analysis was conducted using SAS 9.2.

Results

Central venous BA treatment results in a statistically significant reductions in both ACTH and Cortisol (P<0.01). The distribution in change of ACTH and Cortisol shifted towards negative and significantly away from 0 with median and first, third quartile of -6.15 (-10.25, -2.25) and -4.15 (-6.9, -1.6) respectively. These changes are counter to the stress mediated increase in ACTH and Cortisol levels expected following an invasive procedure.

Conclusions

Reductions in serum ACTH and Cortisol post-BA intervention indicates alterations in the activities of the HPA axis. These hormonal changes can be used as surrogate markers of BA clinical efficacy. This pilot study has potential implications for the treatment of HPA axis dysfunction in pathological states other than MS. Further studies should investigate the long-term endocrine impact of CCSVI treatment.

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Autonomic Dysfunction Testing in Patients Seeking CCSVI Treatment http://www.synergyhealthconcepts.com/autonomic-dysfunction-testing-in-patients-seeking-ccsvi-treatment/ http://www.synergyhealthconcepts.com/autonomic-dysfunction-testing-in-patients-seeking-ccsvi-treatment/#comments Thu, 12 Sep 2013 21:50:10 +0000 http://www.synergyhealthconcepts.com/?p=3407 Authors: M Arata1, P DeGuzman2, F DeBarge-Igoe3 Institutions: 1Synergy Health Concepts, Newport Beach, CA, 2Synergy Health, Newport Beach, CA Enter Objectives / Purpose Statement: Patients seeking treatment for CCSVI at our clinic commonly present with symptoms of autonomic dysfunction: fatigue, interrupted sleep, cognitive impairment, bowel and/or bladder dysfunction, thermal intolerance. Recent analysis by Zohara Sternberg […]

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Authors:

M Arata1, P DeGuzman2, F DeBarge-Igoe3

Institutions:

1Synergy Health Concepts, Newport Beach, CA, 2Synergy Health, Newport Beach, CA

Enter Objectives / Purpose Statement:

Patients seeking treatment for CCSVI at our clinic commonly present with symptoms of autonomic dysfunction: fatigue, interrupted sleep, cognitive impairment, bowel and/or bladder dysfunction, thermal intolerance. Recent analysis by Zohara Sternberg has drawn a parallel between autonomic dysfunction and CCSVI. Heart Rate Variability (HRV) analysis is an established method of identifying autonomic dysfunction. We introduced HRV analysis into our CCSVI pre procedure evaluation protocol. The purpose of this report was to determine the utility of HRV analysis in providing objective evidence of autonomic dysfunction in CCSVI patients.

Method:

Autonomic function was assessed 24 hours pre-procedure. HRV analysis was carried out using the ANS2000, D.E. Hokanson, Inc. Bellevue, WA. A total of 196 patients underwent successful testing. R-R interval variation with deep inspiration was analyzed with determination of the mean circular resultant (MCR).

Results:

One Hundred ninety-six (196) patients were tested. One hundred seventy-eight patients (91%) tested positive for dysautonomia. Twelve patients (6%) were disqualified: eleven patients due to inability to determine a normal reference range secondary to age and one patient due to cardiac artifact. Six patients (3%) tested negative for dysautonomia.

Conclusions:

Assessment of autonomic function with HRV testing allows objective diagnosis of dysautonomia in patients seeking treatment for CCSVI. Further studies are warranted to investigate the relationship between CCSVI and dysautonomia.

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Progressive Improvement in Quality of Life After Jugular Balloon Dilation in Patients with Autonomic Dysfunction http://www.synergyhealthconcepts.com/progressive-improvement-in-quality-of-life-after-jugular-balloon-dilation-in-patients-with-autonomic-dysfunction/ http://www.synergyhealthconcepts.com/progressive-improvement-in-quality-of-life-after-jugular-balloon-dilation-in-patients-with-autonomic-dysfunction/#comments Thu, 12 Sep 2013 21:43:15 +0000 http://www.synergyhealthconcepts.com/?p=3401 Authors: M Arata1, F DeBarge-Igoe2, P Grewal3, S Cen4 Institutions: 1Synergy Health Concepts, Newport Beach, CA, 2Synergy Health, Newport Beach, CA, 3Pacific Interventionalists, Newport Beach, CA, 4Division of Biokinesiology and Physical Therapy University of Southern California, Los Angeles, CA Enter Objectives / Purpose Statement: Autonomic dysfunction has been identified as a co-morbid syndrome in patients […]

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Authors:

M Arata1, F DeBarge-Igoe2, P Grewal3, S Cen4

Institutions:

1Synergy Health Concepts, Newport Beach, CA, 2Synergy Health, Newport Beach, CA, 3Pacific Interventionalists, Newport Beach, CA, 4Division of Biokinesiology and Physical Therapy University of Southern California, Los Angeles, CA

Enter Objectives / Purpose Statement:

Autonomic dysfunction has been identified as a co-morbid syndrome in patients with neurodegenerative disorders. Chronic Cerebrospinal Venous Insufficiency (CCSVI) is a pathophysiologic state whereby there is functional or anatomic obstruction of the internal jugular veins. We have previously ascribed the symptoms of CCSVI to autonomic dysfunction. Further, it has been reported that patients identified with CCSVI report improved QOL parameters after treatment with jugular ballooning. Our purpose was to evaluate the change in quality of life (QOL) after balloon dilation of the jugular veins in patients with symptomatic autonomic dysfunction.

Method:

384 patients treated with jugular ballooning for autonomic dysfunction completed a modified, validated, and standardized MS Quality of Life Inventory Questionnaire prior to procedure (N=384), 1-2month post procedure (N=384), 2-3 month post procedure (N=199), 3-6 months post procedure (N=149), and 6-9 months post procedure (N=2). This questionnaire included Health Status Questionnaire (SF-36), Modified Fatigue Impact Scale (MFIS), MOS Pain Effects Scale (PES), Bladder Control Scale (BLCS), Bowel Control Scale (BWCS), Impact of Visual Impairment Scale (IVIS), Perceived Deficits Questionnaire (PDQ), and Mental Health Inventory (MHI). The SF-36 is composed of two components, the PCS and MCS, each score ranges from 0-100, a higher score indicates improvement. The MFIS score ranges from 0-84, higher score indicates a greater impact of fatigue on daily life. The MOS-PES score ranges from 6-30; a higher score indicates greater impact of pain on daily life. The BLCS score ranges from 0-22, a higher score indicates greater problem with bladder control. BWCS score ranges from 0-26, a higher score indicates greater problem with bowel control. The IVIS score ranges from 0-15, a higher score indicates greater visual impairment on daily activity. The PDQ score ranges from 0-80, a higher score indicates greater perceived cognitive impairment. The MHI score ranges from 0-100, a higher score indicates better mental health. Mixed model (SAS ® 9.2 proc mixed) was used to estimate the trajectory slope (day as unit) of each of the scales.

Results:

There were statistically significant (p=<0.01) improvements in all scales except for Impact of Visual Impairment Scale (p=0.1). The estimated improvements per 100 days for SF-36 (PCS, MCS), MFIS, MOS-PES, BLCS, BWCS, IVIS, PDQ, and MHI are 1.21 (0.24, 2.19), 2.4 (1.43, 3.38), -7.86 (-9.91, -5.8), -1.85 (-2.48, -1.22), -1.33 (-1.88, -0.77), -0.64 (-1.14, -0.14), -0.2 (-0.45, 0.04), -3.59 (-5.12, -2.06), and 3.4 (1.76, 5.05) respectively.

Conclusions:

The quality-of-life of patients with autonomic dysfunction continuously and dramatically improves in 1 to 9 month after jugular ballooning as shown by improved MS QOL questionnaire responses administered pre-procedure and compared to time points post-procedure. Statistical significance was reached in all measured parameters except for IVIS which is borderline significance. Our data suggest that jugular ballooning can be a very effective treatment for patients with autonomic dysfunction.

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The Evolution of CCSVI – A New Understanding and a New Treatment http://www.synergyhealthconcepts.com/the-evolution-of-ccsvi-a-new-understanding-and-a-new-treatment/ http://www.synergyhealthconcepts.com/the-evolution-of-ccsvi-a-new-understanding-and-a-new-treatment/#comments Thu, 18 Jul 2013 22:41:06 +0000 http://www.synergyhealthconcepts.com/?p=3331 Chronic CerebroSpinal Venous Insufficiency (CCSVI) has been described as a hemodynamic disturbance of the CNS venous drainage. The theory being that CCSVI results from obstructing lesions of the extra-cranial veins in the CNS drainage pathway. Venous hypertension, as a result of the impaired venous drainage seen with CCSVI, is postulated to play a role in […]

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ccsvi autonomic dysfunction

Chronic CerebroSpinal Venous Insufficiency (CCSVI) has been described as a hemodynamic disturbance of the CNS venous drainage. The theory being that CCSVI results from obstructing lesions of the extra-cranial veins in the CNS drainage pathway. Venous hypertension, as a result of the impaired venous drainage seen with CCSVI, is postulated to play a role in the pathogenesis of multiple sclerosis (MS). However, subsequent studies have been inconclusive in establishing a relationship between extra-cranial venous abnormalities and manifestations of MS.

Autonomic nervous system dysfunction has been described as a possible explanation for the occurrence of CCSVI by Z. Sternberg. This theory is supported by my clinical experience of autonomic symptoms commonly being present in patients presenting for evaluation of CCSVI. While autonomic symptoms may be variable and diverse in nature, our patients tend to experience fatigue, interrupted sleep, brain fog, thermal intolerance, awakening headache, bowel and bladder dysfunction. Signs of autonomic dysfunction such as low blood pressure (BP), low body temperature and abnormalities in heart rate variability (HRV) are also commonly present.

In my experience, when this constellation of symptoms is present, patients are likely to respond to venous angioplasty. Additionally, the patients showing deviation from normal in systolic and diastolic BP were often corrected in patients after BA. Therefore, normalization of BP and HRV may be used as surrogate markers to assess the utility of therapeutic intervention.

Decentralized venous drainage has been described following spinal cord injury, a common inciting factor for acute autonomic dysfunction. Abnormal cerebral venous drainage may therefore be one of the many manifestations of the autonomic dysfunction rather than a cause as Zamboni has suggested. Another test of autonomic function showing abnormalities in MS patients is HRV. HRV reflects the influence of autonomic system on the function of the heart.

The implications of autonomic dysfunction in the pathology of the cerebral venous system also necessitated a reappraisal of our treatment approach. The physiologic basis of renal denervation served as a theoretical model. Renal denervation therapy, with its transvascular augmentation of periadventitial autonomic fibers, offers an alternate route to modulate the ANS function. Therefore, we have modified Zamboni’s technique of angioplasty to extend beyond dilation of venous obstructing lesion, in an effort to effect autonomic stimulation. This modification involved delivery of mechanical energy to the periadventitial fibers associated with the internal jugular veins, as well as the renal vein. This modified technique can best be described by the term Transvascular Autonomic Modulation (TVAM).

Find out more about TVAM here.

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Heart Rate Variability Response to Jugular Ballooning in Patients with Symptomatic Autonomic Dysfunction http://www.synergyhealthconcepts.com/heart-rate-variability-response-to-jugular-ballooning-in-patients-with-symptomatic-autonomic-dysfunction/ http://www.synergyhealthconcepts.com/heart-rate-variability-response-to-jugular-ballooning-in-patients-with-symptomatic-autonomic-dysfunction/#comments Mon, 13 May 2013 23:30:09 +0000 http://www.synergyhealthconcepts.com/?p=2929 Michael Arata, MD, Frances DeBarge-Igoe, RN, Piay DeGuzman Synergy Health Concepts, Newport Beach, CA. BACKGROUND: Jugular venous angioplasty has been performed as a treatment for a condition described as CCSVI. The efficacy of this treatment been challenged as being attributed to a placebo effect or that objective data is lacking and reported responses to treatment […]

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Michael Arata, MD, Frances DeBarge-Igoe, RN, Piay DeGuzman Synergy Health Concepts, Newport Beach, CA.

BACKGROUND: Jugular venous angioplasty has been performed as a treatment for a condition described as CCSVI. The efficacy of this treatment been challenged as being attributed to a placebo effect or that objective data is lacking and reported responses to treatment thus far have been only subjective in nature. The FDA states, “there is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS or improves the quality of life for MS patients.” observation of patients’ presenting symptoms for CCSVI treatment has lead to the hypothesis that these symptoms are related to autonomic dysfunction rather than a new entity, CCSVI or MS. Normalization of blood pressure post jugular venous angioplasty has also been observed and supports to the hypothesis of autonomic dysfunction. Heart rate variability (HRV) testing was therefore incorporated for assessment of autonomic dysfunction in patients undergoing jugular vein angioplasty.

METHODS: Autonomic function was assessed 24 hours pre procedure and 24 hours after jugular ballooning. Hrv analysis was carried out using the ans2000, D.E. Hokanson, inc. Bellevue, WA. A total of 24 patients underwent successful testing both before and after jugular angioplasty. R-r interval variation with deep inspiration was analyzed with determination of the mean circular resultant (mcr).

RESULTS: Sixteen (66.7%) patients saw and improvement in mcr 24 hours after jugular balloon dilation. In four (16.7%) patients the improvement was such that their mcr was normalized.

CONCLUSION: HRV testing allows objective assessment of response to treatment following jugular venous angioplasty in patients with symptomatic autonomic dysfunction. Jugular venous angioplasty should be studied further as a potential treatment of autonomic dysfunction.

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