scholarly journals Design of a Catheter-Based Device for Performing Percutaneous Chordal-Cutting Procedures

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
Alexander H. Slocum ◽  
William R. Bosworth ◽  
Anirban Mazumdar ◽  
Miguel A. Saez ◽  
Martin L. Culpepper ◽  
...  
Keyword(s):  
Heart Surgery ◽  
Open Heart Surgery ◽  
The United States ◽  
Functional Mitral Regurgitation ◽  
Functional Requirements ◽  
Design Concepts ◽  
Percutaneous Catheter ◽  
Receive Treatment ◽  
To Receive ◽  
Viable Method

This paper focuses on the design and implementation of a percutaneous catheter-based device to provide physicians with an externally controlled tool capable of manipulating and cutting specific chordae tendinae within the heart to alleviate problems associated with some forms of mitral valve (MV) regurgitation. In the United States alone, approximately 500,000 people develop ischemic or functional mitral regurgitation per year. Many of these patients do not possess the required level of health necessary to survive open-heart surgery, and the development of a chordal cutting procedure and device is needed to allow these patients to receive treatment. A deterministic design process was used to generate several design concepts and then evaluate and compare each concept based on a set of functional requirements. A final concept to be alpha prototyped was then chosen, further developed, and fabricated. Experiments showed that the design was capable of locating and grabbing a chord and that ultrasound imaging is a viable method for navigating the device inside of the human body. Once contact between the chord and radio-frequency (RF) ablation tip was confirmed, the chord was successfully ablated.

scholarly journals Design of a Catheter-Based Device for Performing Percutaneous Chordal-Cutting Procedures

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
A. H. Slocum ◽  
W. R. Bosworth ◽  
A. Mazumdar ◽  
M. A. Saez ◽  
M. L. Culpepper ◽  
...  
Keyword(s):  
Mitral Valve ◽  
Design Process ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Mitral Valve Regurgitation ◽  
The United States ◽  
Functional Requirements ◽  
Device Design ◽  
Design Concepts ◽  
Rapid Design

In this paper we detail the rapid design, fabrication and testing of a percutaneous catheterbased device that is envisioned to enable externally controlled manipulation and cutting of specific chordae tendinae within the heart. The importance of this work is that it (a) provides a means that surgeons may use to alleviate problems associated with some forms of mitral valve regurgitation and (b) demonstrates how a deterministic design process may be used to drive design innovation in medical devices while lowering development cost/time/resources. In the United States alone, approximately 500,000 people develop ischemic or functional MR per year. A chordal cutting procedure and device could allow many patients, who would otherwise be unable to survive open-heart surgery, to undergo a potentially life-saving operation at reduced risk. The design process has enabled us to generate a solution to this problem in a relatively short time. A deterministic design process was used to generate several design concepts and then evaluate and compare each concept based on a set of functional requirements. A final concept to be alpha prototyped was then chosen, optimized, and fabricated. The design process made it possible to make rapid progress during the project and to achieve a device design that worked the first time. This approach is important to medical device design as it reduces engineering effort, cost, and the amount of time spent in iterative design cycles. An overview of the design process will be presented and discussed within the context of a specific case study–the rapid design/fabrication of a chordal cutting device. Experimental results will be used to assess: (i) The performance of the catheter in maneuvering into the heart and grasping various structures. (ii) The effectiveness of the catheter's RF ablation tip at cutting chordae inside of a heart. In the first experiment, the catheter was guided to the basal chordae under direct visualization, which showed that the catheter is capable of successfully grasping a chord. During the second experiment, ultrasound was shown to be a viable method of visualizing the catheter within the heart. During this experiment, once contact between the chord and RF ablator tip was confirmed, the chord was successfully ablated. We will also discuss experiments that are currently underway to visualize the catheter utilizing a Trans-Esophageal Echo probe, as well as imaging the mitral valve from the apex of the heart with a laparoscope so that video of the basal chord being grasped and cut can be acquired on a heart whose anatomical structures are intact. A brief synopsis will then be given of how the design process has been used in research and educational collaborations between MIT and local hospitals.

scholarly journals Disparities in Opioid Use Disorder Treatment Admissions in the United States

2020 ◽  
Vol 7 (1) ◽  
pp. 85-93
Author(s):  
Peter Mallow ◽  
Michael Mercado ◽  
Michael Topmiller
Keyword(s):  
United States ◽  
Wait Time ◽  
The United States ◽  
Opioid Use Disorder ◽  
P Value ◽  
Opioid Use ◽  
Data Set ◽  
Significant Difference ◽  
Receive Treatment ◽  
To Receive

Objectives: The Cincinnati region has been at the epicenter of the nation’s unfolding opioid epidemic. The objectives of this study were twofold: (1) to compare the Cincinnati region to the United States in length of time to obtain treatment and planned medication-assisted therapy for the treatment for opioid use disorder (OUD); and (2) to assess racial disparities within the Cincinnati region in wait time and type of treatment. Methods: The 2017 Treatment Episode Data Set: Admissions (TEDS-A) from the Substance Abuse and Mental Health Services Administration (SAMHSA) was used to identify a cohort of eligible individuals with a primary substance use of opioids, including opioid derivatives. Logistic regression models were performed to assess the differences for treatment wait time and type of planned treatment. Model covariates included patient demographics and socioeconomic characteristics. Three different models were performed to assess the influence of covariates of the outcomes. Results: There were 678 766 US and 3298 Cincinnati region individuals admitted for OUD treatment in 2017. The rate per 1000 for treatment admissions was 2.08 and 1.51 (P value < 0.0001) for the United States and Cincinnati, respectively. The fully saturated regression results found that the odds of Cincinnati individuals receiving planned medication-assisted therapy were 0.497 (95% CI, 0.451–0.546; P value < 0.001). The odds of waiting longer for treatment in Cincinnati were higher than in the United States as a whole: 2.33 (95% CI, 2.19–2.48; P value < 0.001). In Cincinnati, there were 3102 Caucasian, 123 African American, and 73 Other admissions. The fully saturated model results found that Caucasians and Other had an increased likelihood of receiving planned medication-assisted therapy (OR 1.89, P value 0.039; OR 7.07, P value 0.002, respectively) compared to African Americans. Within Cincinnati, there was not a statistically significant difference in the likelihood of waiting time to receive treatment by race. Conclusion: Individuals seeking treatment for OUD in Cincinnati were less likely to receive planned medication-assisted therapy and were more likely to wait longer than individuals in the United States as a whole. These results suggest that the demand for treatment is greater than the supply in Cincinnati. Within Cincinnati, there does not appear to be a racial disparity in treatment type or length of time to receive treatment for OUD.

A Review of Cardiovascular Disease and Treatment Differences in Women

2003 ◽  
Vol 16 (3) ◽  
pp. 157-163 ◽  
Author(s):  
Mary H. Parker
Keyword(s):  
Risk Factors ◽  
Cardiovascular Disease ◽  
The United States ◽  
Evidence Based ◽  
Study Enrollment ◽  
United States Today ◽  
Receive Treatment ◽  
Based Medicine ◽  
To Receive ◽  
Significant Health

Cardiovascular disease (CVD) is a significant health care problem in the United States today. Women comprise an increasing component of the population affected by this disease. Recent reports have suggested that women are not enrolled in adequate numbers in major clinical studies and, furthermore, are less likely to receive treatment as recommended by evidence-based medicine guidelines. Historical differences in the investigation and treatment of cardiovascular disease between women and men are discussed. Reasons for differences in study enrollment of women are proposed. Efforts by the Food and Drug Administration to improve data collection in women are outlined. The influence of major risk factors, including smoking, hyperlipidemia, and hypertension, on development and progression of CVD is addressed. Major trials of CVD and heart failure are examined. An assessment of progress toward a goal of gender treatment equality is made.

Effect of modified ultrafiltration on the inflammatory response in paediatric open-heart surgery: a prospective, randomized study

Perfusion ◽  
2002 ◽  
Vol 17 (5) ◽  
pp. 327-333 ◽  
Author(s):  
Michelle S Chew ◽  
Vibeke Brix-Christensen ◽  
Hanne B Ravn ◽  
Ivan Brandslund ◽  
Emmy Ditlevsen ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Clinical Outcome ◽  
Heart Surgery ◽  
Randomized Study ◽  
Open Heart Surgery ◽  
Coagulation System ◽  
Arterial Oxygen ◽  
Markers Of Inflammation ◽  
Postoperative Oxygenation ◽  
To Receive

Modified ultrafiltration (MUF) is often used in conjunction with paediatric cardiac surgery with cardiopulmonary bypass (CPB) and is thought to improve clinical outcome. It is unclear whether these improvements (if any) are due to the removal of inflammatory mediators. In this prospective study, 18 children aged 12-24 months undergoing uncomplicated cardiac surgery with methylprednisolone added in the pump prime were randomized to receive CPB with ( n= 10) and without ( n= 8) MUF. Cytokines (TNFα, IL-6, IL- 1β, IL-10, IL-1ra), complement split products (C3d, C4d) and coagulation system activation (F1+ 2, ATIII) were measured pre-, peri- and up to 48 h postoperatively. For clinical outcome, the alveolar-arterial oxygen (A-a) gradient, transfusion requirement, drain loss, mean blood pressure and requirement for inotropic support were registered up to 24 h postoperatively. Our results show an improvement in postoperative oxygenation as well as a tendency towards decreased drain loss and improved haemodynamics in the MUF group. There were no intergroup differences detectable for TNFα, IL-1β, IL-1ra, complement and coagulation markers. We conclude that MUF in itself does not significantly influence TNFα, IL-1β, IL-1ra and the complement and coagulation profiles in children undergoing cardiac surgerywith CPB. Despite this, there was some evidence for improved clinical outcome. Our results do not support that MUF improves postoperative organ function by modulation of the measured markers of inflammation.

Abstract 16538: The Impact of Institutional Design on Transcatheter Aortic Valve Replacement Complication Rates in the United States

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Sadip Pant ◽  
Samir Patel ◽  
Harsh Golwala ◽  
Nilesh Patel ◽  
Apurva Badheka ◽  
...  
Keyword(s):  
United States ◽  
Heart Surgery ◽  
Institutional Design ◽  
Open Heart Surgery ◽  
Hospital Setting ◽  
The United States ◽  
Hospital Inpatient ◽  
Complication Rates ◽  
Hospital Size ◽  
The Impact

Introduction: With the technical advancements and expanding indications, utilization of TAVR is on the rise among various institutions in the United States .While appropriate patient selection and better techniques are essential to improving outcomes, the impact of institutional design (or hospital setting) on outcomes with TAVR has yet to be examined. Objective: The objective of our study is to compare TAVR complication rates among teaching vs non-teaching centers in the United States Methods: We used Healthcare Cost and Utilization Project - National Inpatient Sample (NIS) data , the largest all payer database of hospital inpatient stay available in United States, to identify patients (age ≥18 years) who underwent TAVR from Jan-Dec 2012. We constructed multivariable models to determine independent predictors (age, sex, race, Charlson’s comorbidity index, hospital size, hospital location and TAVR approach) of TAVR-associated complications. Statistical analysis was performed using Stata IC 11.0 (Stata-Corp, College Station, TX). Results: We identified 7,405 TAVR procedures performed in the United States in 2012. 88% of TAVR were performed in teaching centers. There was no difference in mortality following TAVR between teaching and non-teaching centers. The occurrence of any in-hospital complication was lower in teaching centers as compared to non-teaching centers (42% vs. 50%, p<0.001). Rates of individual complications in teaching vs. non-teaching centers are illustrated in the figure. In adjusted analysis, hemorrhage requiring transfusion (13.2% vs. 20.8%, p<0.001), renal complications requiring dialysis (1.2% vs. 2.3%, p=0.009), respiratory complications (7.5% vs. 11%, p<0.001) and complications requiring open-heart surgery (2% vs. 4.6%, p<0.001) were lower in teaching centers as compared to non-teaching centers. Vascular access site complications, pacemaker insertion, pericardial and neurological complications were similar between teaching and non-teaching centers (Figure). Conclusion: Institutional design impacts TAVR complication rates albeit no difference in mortality. In general, complication rates are lower in teaching centers compared to non-teaching centers.

Complement activation during and after open-heart surgery is only marginally affected by the choice of fluid for volume replacement

Perfusion ◽  
1996 ◽  
Vol 11 (4) ◽  
pp. 326-332 ◽  
Author(s):  
JL Svennevig ◽  
S. Tølløfsrud ◽  
U. Kongsgaard ◽  
H. Noddeland ◽  
B. Mohr ◽  
...  
Keyword(s):  
Complement Activation ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Volume Replacement ◽  
Open Heart ◽  
Coronary Artery Surgery ◽  
Dextran 70 ◽  
Activation Products ◽  
To Receive ◽  
Terminal Complement

Forty patients undergoing CPB for coronary artery surgery, using a standardized technical setting, were randomized to receive either Ringer's acetate, dextran 70 (Macrodex), polygeline (Haemaccel) or albumin 4% for volume replacement during and after surgery. The choice of fluid did not affect early complement activation (C3 activation products). Higher values of the terminal complement complex (TCC) were found only at the end of the operation in patients receiving polygeline. There were no differences between any two of the four groups during the postoperative course. The use of blood transfusion or autotransfusion and the degree of haemodilution and hypothermia did not affect complement activation. We conclude that complement activation in association with open-heart surgery is only marginally affected by the choice of fluid for volume replacement.

Utilisation of early intervention services in infants with congenital heart disease following open-heart surgery

2020 ◽  
pp. 1-6
Author(s):  
Caroline West ◽  
Sunkyung Yu ◽  
Ray Lowery ◽  
Caren S. Goldberg ◽  
Karen Uzark
Keyword(s):  
Early Intervention ◽  
Heart Surgery ◽  
Single Ventricle ◽  
Open Heart Surgery ◽  
Open Heart ◽  
Genetic Abnormality ◽  
Early Intervention Services ◽  
Factors Associated ◽  
Intervention Services ◽  
To Receive

Abstract Objective: To examine the use of early intervention services in infants with CHD after open-heart surgery and identify factors associated with receipt of services. Study design: Surveys were administered to caregivers of infants who underwent open-heart surgery before 1 year of age at a single institution between July, 2017 and July, 2018. Information regarding the infant’s use of early intervention services and the caregiver’s experience with the programme was obtained. Clinical data were retrieved from the medical record review. Logistic regression identified factors associated with receipt of services. Results: The study included 158 eligible infants. Ninety-eight caregivers (62%) completed the surveys. Of those surveyed, 53.1% of infants were currently or previously enrolled in early intervention services. Infants most frequently received physical therapy (76.9%). The majority of caregivers found services to be moderately/very helpful (92.3%) and sufficient for their child (76.9%). In the univariate analysis, single-ventricle disease, known syndrome/genetic abnormality, extracardiac anomaly, and longer intensive care and hospital length of stay were associated with receipt of services. Single-ventricle disease (p = 0.004) and known syndrome/genetic abnormality (p < 0.0001) remained independently associated with receipt of services in the multivariable analysis. Conclusion: Amongst infants at risk for neurodevelopmental deficits, approximately half received services after open-heart surgery. Caregivers expressed satisfaction with the programme. While infants with single-ventricle disease and a known syndrome/genetic abnormality were more likely to receive early intervention services, many at-risk infants with CHD failed to receive services. Further research is needed to identify barriers to early intervention services and promote developmental outcomes.

Effects of Edge-to-Edge Repair on Chordal Tension of Prolapsed Mitral Valve

2009 ◽  
Author(s):  
Zhaoming He ◽  
Suveen Emmadi ◽  
Shamik Bhattacharya
Keyword(s):  
Mitral Valve ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
The United States ◽  
Posterior Leaflet ◽  
Special Configuration ◽  
Tension Distribution ◽  
Before And After ◽  
Prolapsed Mitral Valve ◽  
Leaflet Coaptation

Edge-to-edge repair (ETER) was introduced to correct mitral valve (MV) regurgitation and has demonstrated efficacy in a spectrum of MV diseases [1], especially MV prolapse. This technique changes MV geometric configuration by suturing the anterior and posterior leaflets at central or commissural edges (depending on lesion), and consequently alters MV mechanics. MV prolapse is the most common heart valve abnormality in the United States. It is mainly caused by chordal rupture or elongation in which imbalanced chordal lengths protrude MV anterior and/or posterior leaflets. Chordal repair or leaflet resection are common surgical procedures in an open heart surgery. ETER is also effective in treatment of MV prolapse and preferred because of potential percutaneous application of the similar procedure. However, ETER restore leaflet coaptation from a prolapsed MV and may alter leaflet stress and chordal tension distribution. Our hypothesis is that ETER changes leaflet and chord special configuration of a prolapsed MV and thus chordal tensions as compared with normal and prolapsed MVs. The aim of the current study was to investigate tensions of marginal, strut chordae of anterior leaflet, and of marginal, intermediate chordae of posterior leaflet during systole before and after ETER on the MV with a prolapsed posterior leaflet. Hypothesis is tested by comparison of chordal tension change.

The cardiopulmonary bypass pump-priming fluid and nitrogen balance after open-heart surgery in adults

Perfusion ◽  
1986 ◽  
Vol 1 (1) ◽  
pp. 47-52
Author(s):  
CK McKnight ◽  
MJ Elliott ◽  
MP Holden ◽  
DT Pearson
Keyword(s):  
Cardiopulmonary Bypass ◽  
Heart Valve ◽  
Nitrogen Balance ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Valve Surgery ◽  
Heart Valve Surgery ◽  
Open Heart ◽  
To Receive ◽  
Better Than

Different crystalloid cardiopulmonary bypass pump-priming fluids provide very different substrate loads to patients undergoing open-heart surgery. As a result they may modulate the endocrine milieu, and thus might be expected to alter postoperative nitrogen balance. To test this hypothesis, 24 adult patients undergoing open-heart valve surgery were randomized into four matched groups each to receive a different prime, namely: Hartmann's solution, Plasmalyte 148R, Solution 11 R and a prime consisting of equal volumes of Hartmann's solution and 5% dextrose. Accurate nitrogen balance studies were obtained each 24 hours from one day preoperatively to seven days postoperatively. The results obtained demonstrated that postoperative nitrogen balance was unaffected by the nature of the crystalloid pump prime. Nitrogen balance in the patients studied was better than that reported from other centres in similar patients.

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