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1.
J Soc Cardiovasc Angiogr Interv ; 1(4): 100309, 2022.
Article in English | MEDLINE | ID: mdl-39131936

ABSTRACT

Background: We aim to establish the degree of agreement related to gradient measurement during transcatheter aortic valve replacement (TAVR) between the OpSens OptoWire III and its new proprietary TAVR algorithm and hemodynamic value derived by catheterization and echocardiogram (transthoracic echocardiogram and transesophageal echocardiogram). Methods: The current study was a prospective, single-arm, single-center study. All subjects underwent hemodynamic assessment before and after TAVR using standard hemodynamic assessment using 2 pigtails, transthoracic echocardiogram, transesophageal echocardiogram, and the OpSens OptoWire III. The primary end point was the final post-TAVR mean gradient correlation between OpSens OptoWire III and hemodynamic values derived by catheterization. Results: Between July 2021 and September 2021, 20 patients were enrolled. The median age was 79 [6.5] years, and 9 (45%) patients were female. The mean gradient before TAVR derived by 2-pigtail technique and the mean gradient using the OpSens OptoWire III were similar (35 ± 14 mm Hg vs 35 ± 14 mm Hg, P = 1.00), with an absolute mean difference of 2.2 ± 3.5 mm Hg and a strong correlation (r = 0.96, P < .0001). After TAVR, the mean gradient derived by 2-pigtail technique and the mean gradient using the OpSens OptoWire III were similar (2.2 ± 3.5 vs 2.8 ± 2.7, P = .16), with an absolute mean difference of 1.2 ± 1.3 mm Hg and a strong correlation (r = 0.89, P < .0001). Conclusions: Hemodynamic assessment derived by the OpSens OptoWire III wire and its new TAVR algorithm demonstrated excellent correlation with measurements derived by 2 pigtails both before and after TAVR. Integration of this new technology within a dedicated TAVR wire with live hemodynamic assessment could bring meaningful value to TAVR operators.

2.
J Invasive Cardiol ; 32(7): 255-261, 2020 Jul.
Article in English | MEDLINE | ID: mdl-32507753

ABSTRACT

OBJECTIVES: To evaluate the safety and accuracy of the Early Bird Bleed Monitoring System (EBBMS; Saranas) for the detection of access-site related bleeds in humans undergoing endovascular procedures. BACKGROUND: Bleeding complications after endovascular procedures are frequent and associated with poor prognosis. The EBBMS is a novel technology designed to detect in real time the onset, progression, and severity of internal bleeds. METHODS: The EBBMS was used during and after endovascular procedures, either as a venous or arterial access sheath. The primary endpoint was the level of agreement in bleed detection between the Saranas EBBMS and postprocedural computed tomography. RESULTS: From August 2018 to December 2018, a total of 60 patients from five United States sites were enrolled and underwent elective endovascular procedures (transcatheter aortic valve replacement [67%], percutaneous coronary intervention [13%], percutaneous ventricular assist device [8%], balloon aortic valvuloplasty [7%], transcatheter mitral valve repair/replacement [4%], and endovascular aneurysmal repair [2%]). The EBBMS detected the absence of bleeds in 21 patients (35%) and bleeds in 39 patients (65%), with bleeding severity level 1 in 20 patients (33%), level 2 in 15 patients (25%), and level 3 in 4 patients (7%). Bleeding detection occurred during the procedure in 31% of patients and post procedure in 69% of patients. The level of agreement between the EBBMS and computed tomography scan was high (Cohen's kappa=0.84). No device-related complications were reported. CONCLUSIONS: The EBBMS was safe across a variety of endovascular procedures and detected bleeding events with a high level of agreement with postprocedural computed tomography scan.


Subject(s)
Endovascular Procedures , Hemorrhage , Balloon Valvuloplasty , Endovascular Procedures/adverse effects , Hemorrhage/diagnosis , Hemorrhage/epidemiology , Hemorrhage/etiology , Humans , Transcatheter Aortic Valve Replacement , Treatment Outcome
3.
Ann Thorac Surg ; 103(1): e57-e59, 2017 Jan.
Article in English | MEDLINE | ID: mdl-28007276

ABSTRACT

Transcatheter valve implantation in the mitral position with severe calcific mitral stenosis has been described in patients who are at an increased risk for conventional mitral valve surgical procedures. We report the direct deployment of the Sapien 3 valve in the mitral position with severe mitral annular calcification through a sternotomy in an arrested heart in two cases.


Subject(s)
Calcinosis/complications , Cardiomyopathies/complications , Heart Valve Prosthesis Implantation/methods , Mitral Valve Stenosis/surgery , Mitral Valve/surgery , Aged , Aged, 80 and over , Calcinosis/diagnosis , Calcinosis/surgery , Cardiomyopathies/diagnosis , Cardiomyopathies/surgery , Echocardiography, Three-Dimensional , Echocardiography, Transesophageal , Female , Humans , Male , Mitral Valve/diagnostic imaging , Mitral Valve Stenosis/diagnosis , Mitral Valve Stenosis/etiology , Severity of Illness Index
4.
Am J Cardiol ; 115(9): 1254-9, 2015 May 01.
Article in English | MEDLINE | ID: mdl-25772738

ABSTRACT

The goal of this study was to assess outcomes of patients who underwent implantation of left ventricular assist devices (LVADs) at nontransplantation mechanical circulatory support centers. As the availability of LVADs for advanced heart failure has expanded to nontransplantation mechanical circulatory support centers, concerns have been expressed about maintaining good outcomes. Demographics and outcomes were evaluated in 276 patients with advanced heart failure who underwent implantation of LVADs as bridge to transplantation or destination therapy at 27 open-heart centers. Baseline characteristics, operative mortality, length of stay, readmission rate, adverse events, quality of life, and survival were analyzed. The overall 30-day mortality was 3% (8 of 276), and survival rates at 6, 12, and 24 months, respectively, were 92±2%, 88±3%, and 84±4% for the bridge-to-transplantation group and 81±3%, 70±5%, and 63±6% for the destination therapy group, comparable with results published by the national Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). The median length of stay for all patients was 21 days. Bleeding was the most frequent adverse event. Stroke occurred in 4% (bridge to transplantation) and 6% (destination therapy) of patients. Quality-of-life measures and 6-minute walk distances showed sustained improvements throughout support. In conclusion, outcomes with LVAD support at open-heart centers are acceptable and comparable with results from the INTERMACS registry. With appropriate teams, training, center commitment, and certification, LVAD therapy is being disseminated in a responsible way to open-heart centers.


Subject(s)
Cardiac Care Facilities , Heart Failure/mortality , Heart Failure/therapy , Heart-Assist Devices , Aged , Female , Heart Transplantation , Humans , Length of Stay , Male , Middle Aged , Patient Readmission/statistics & numerical data , Quality of Life , Retrospective Studies , Survival Rate , Treatment Outcome
5.
J Thorac Cardiovasc Surg ; 143(4): 926-35, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22285327

ABSTRACT

OBJECTIVE: The study objective was to determine the effects of implementing a blood conservation algorithm on blood product use and outcomes in a community cardiac surgery program. METHODS: A blood management strategy including lower hemoglobin transfusion threshold and algorithm-driven decisions was adopted. Intraoperatively, point-of-care testing was used to avoid inappropriate component transfusion. A low prime perfusion circuit was adopted. Blood was withdrawn from patients before initiating bypass when possible. Patients undergoing coronary and valve procedures were included. Outlier patients receiving more than 10 units packed red blood cells were excluded. Data were collected for 6 months as a baseline group (group I). A 3-month period of program implementation was allotted. Data were subsequently collected for 6 months and comprised the study patients (group II). Prospective data were collected on demographics, blood use, and outcomes. RESULTS: Group I comprised 481 patients, and group II comprised 551 patients. Group II received fewer units of packed red blood cells, fresh-frozen plasma, and cryoprecipitate than group I. There was no difference in platelets transfused. Total blood product use was reduced by 40% in group II (P < .001). The overall 30-day mortality was 1.3%. There were no differences in mortality, reoperation for bleeding, or other postoperative outcomes between the groups. CONCLUSIONS: Implementation of a comprehensive blood conservation algorithm can be rapidly introduced, leading to reductions in blood and component use with no detrimental effect on early outcomes. Point-of-care testing can direct component transfusion in coagulopathic cases, with most coagulopathic patients requiring platelets. Further research will determine the effects of reduced transfusions on long-term outcomes.


Subject(s)
Blood Loss, Surgical/prevention & control , Blood Transfusion , Cardiac Surgical Procedures , Community Health Services/organization & administration , Postoperative Hemorrhage/prevention & control , Adult , Aged , Aged, 80 and over , Algorithms , Biomarkers/blood , Blood Coagulation Tests , Blood Transfusion/mortality , Blood Transfusion/statistics & numerical data , Blood Transfusion, Autologous , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/mortality , Chi-Square Distribution , Decision Support Techniques , Female , Hemoglobins/analysis , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , New Jersey , Platelet Count , Point-of-Care Systems , Postoperative Hemorrhage/etiology , Predictive Value of Tests , Program Evaluation , Prospective Studies , Reoperation , Time Factors , Transfusion Reaction , Treatment Outcome , Young Adult
6.
Ann Thorac Surg ; 87(1): 36-44; discussion 44-5, 2009 Jan.
Article in English | MEDLINE | ID: mdl-19101265

ABSTRACT

BACKGROUND: Previous studies have reported an 11% to 75% incidence of postoperative cognitive decline among cardiac surgery patients. The INVOS Cerebral Oximeter (Somanetics Corp, Troy, MI) is a Food and Drug Administration approved device that measures regional cerebral oxygen (rSo(2)) saturation. The purpose of this study is to examine whether decreased rSo(2) predicts cognitive decline and prolonged hospital stay after coronary artery bypass grafting (CABG). METHODS: The rSo(2) was monitored intraoperatively in a cohort of primary CABG patients. Patients were prospectively randomized to a blinded control group or an unblinded intervention group. Cognitive function was assessed preoperatively, postoperatively, and at 3 months using a battery of standardized neurocognitive tests. Cognitive decline was defined as a decrease of one standard deviation or more in performance on at least one neurocognitive measure. The rSo(2) desaturation score was calculated by multiplying rSo(2) below 50% by time (seconds). Multivariate logistic regression models were used to assess cognitive decline and hospital stay. The change in cognitive performance was also assessed using a multivariate linear regression model. RESULTS: Patients with rSo(2) desaturation score greater than 3,000%-second had a significantly higher risk of early postoperative cognitive decline [p = 0.024]. Patients with rSo(2) desaturation score greater than 3,000%-second also had a near threefold increased risk of prolonged hospital stay (>6 days) [p = 0.007]. CONCLUSIONS: Intraoperative cerebral oxygen desaturation is significantly associated with an increased risk of cognitive decline and prolonged hospital stay after CABG.


Subject(s)
Cognition Disorders/diagnosis , Cognition Disorders/etiology , Coronary Artery Bypass/adverse effects , Hypoxia, Brain/diagnosis , Aged , Cerebrovascular Circulation/physiology , Coronary Artery Bypass/methods , Double-Blind Method , Female , Follow-Up Studies , Humans , Hypoxia, Brain/prevention & control , Length of Stay , Logistic Models , Male , Middle Aged , Monitoring, Intraoperative/methods , Multivariate Analysis , Neuropsychological Tests , Oximetry , Oxygen Consumption/physiology , Postoperative Complications/diagnosis , Predictive Value of Tests , Preoperative Care/methods , Probability , Prospective Studies , Reference Values , Risk Factors , Severity of Illness Index , Statistics, Nonparametric , Treatment Outcome
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