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News Article | October 31, 2016
Site: www.prnewswire.co.uk

DURHAM, North Carolina, Oct. 31, 2016 /PRNewswire/ -- Micell Technologies, Inc. (Micell) today announced that it presented five-year clinical safety and efficacy results from the DESSOLVE I and II trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent®). MiStent is designed to optimize vessel healing and long-term clinical performance in patients with coronary artery disease, and the presented data demonstrate sustained desirable clinical outcomes. These results were presented at the 28th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference. TCT, the world's largest educational meeting focused on interventional cardiovascular medicine, is being held in Washington, D.C., October 29 – November 2. In a session titled "Emerging Bioresorbable Polymer-Based Metallic DES", five-year results were presented from the DESSOLVE I and II clinical studies, which demonstrated a combined (DES I and II) target lesion revascularization (TLR) rate of 2.7% at five years. No probable or definite stent thromboses were reported in either study through five-year follow-up. David E. Kandzari, M.D., Director of Interventional Cardiology and Interventional Cardiology Research for Piedmont Heart Institute of Atlanta, Ga., made the presentation. Dr. Kandzari commented, "These results from DESSOLVE I and II validate our initial hypothesis that MiStent's unique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus, permits faster and stable vessel healing that translates to exceptional long-term outcomes." Dean J. Kereiakes, M.D., Medical Director of The Christ Hospital Heart & Vascular Center and The Lindner Research Center, Cincinnati, Ohio, also presented data on the five-year results in a poster session. Dr. Kereiakes concluded, "This pooled analysis of patients treated with MiStent, which has a linear drug release and ultra-thin-strut, cobalt chromium stent design, suggests excellent long term safety and efficacy of this novel coronary stent." Micell's patented supercritical fluid technology allows for a rigorously controlled coating of the drug and polymer, whereby the drug is applied to a bare-metal stent in a dry powder, crystalline form. This preserves its morphology and optimizes its pharmacokinetic (distribution and absorption) profile. MiStent also leverages the benefits of a cobalt chromium coronary stent system -- a state-of-the-art, ultra-thin-strut metallic stent that has demonstrated excellent deliverability, conformability and flexibility. Dennis Donohoe, M.D., Micell's Chief Medical Advisor, remarked, "MiStent uniquely provides continued vascular drug delivery for nine months -- even after its bioresorbable polymer coating has been fully absorbed, which occurs over the course of 90 days." Dr. Donohoe continued, "Studies of MiStent to date have demonstrated a desirable lack of late lumen loss over 18 months, a characteristic that makes MiStent a clinically meaningful improvement in treating patients with coronary artery disease." About MiStent® MiStent is designed to optimize healing and clinical performance in patients with coronary artery disease. The rapidly absorbable coating of MiStent, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for extended local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents and improve long-term clinical outcomes. EU approval of MiStent was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Micell also completed enrollment in December 2015 of DESSOLVE III, a 1,400 patient, 20 center, randomized clinical trial comparing MiStent to Xience Everolimus Eluting Coronary Stent System® (Xience). DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent and Xience in a "real world, all-comers" patient population. Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome, and qualified for percutaneous coronary interventions. The primary endpoint for this trial is a non-inferiority comparison of target lesion failure (TLF) of the MiStent group versus the Xience group at 12 months post-procedure. The 12-month primary endpoint results for DESSOLVE III are expected to be released in the first half of 2017. MiStent has received CE marking, but is not approved for sale in the United States. Caution Regarding Forward-Looking Statements This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as "anticipates," "estimates," "expects," "projects," "intends," "plans," "believes" and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of MiStent in Europe and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of, and expectations about, future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to, the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent in other jurisdictions; the successful development and commercialization of MiStent in Europe and other markets; the ability of MiStent to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward-looking statement contained in this press release. Micell, Micell Technologies, the Micell Logo, MiStent and MiStent SES are among the trademarks of Micell Technologies, Inc.


DURHAM, North Carolina, Oct. 31, 2016 /PRNewswire/ -- Micell Technologies, Inc. (Micell) today announced that it presented five-year clinical safety and efficacy results from the DESSOLVE I and II trials of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent®). MiStent is designed to optimize vessel healing and long-term clinical performance in patients with coronary artery disease, and the presented data demonstrate sustained desirable clinical outcomes. These results were presented at the 28th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference. TCT, the world's largest educational meeting focused on interventional cardiovascular medicine, is being held in Washington, D.C., October 29 – November 2. In a session titled "Emerging Bioresorbable Polymer-Based Metallic DES", five-year results were presented from the DESSOLVE I and II clinical studies, which demonstrated a combined (DES I and II) target lesion revascularization (TLR) rate of 2.7% at five years. No probable or definite stent thromboses were reported in either study through five-year follow-up. David E. Kandzari, M.D., Director of Interventional Cardiology and Interventional Cardiology Research for Piedmont Heart Institute of Atlanta, Ga., made the presentation. Dr. Kandzari commented, "These results from DESSOLVE I and II validate our initial hypothesis that MiStent's unique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus, permits faster and stable vessel healing that translates to exceptional long-term outcomes." Dean J. Kereiakes, M.D., Medical Director of The Christ Hospital Heart & Vascular Center and The Lindner Research Center, Cincinnati, Ohio, also presented data on the five-year results in a poster session. Dr. Kereiakes concluded, "This pooled analysis of patients treated with MiStent, which has a linear drug release and ultra-thin-strut, cobalt chromium stent design, suggests excellent long term safety and efficacy of this novel coronary stent." Micell's patented supercritical fluid technology allows for a rigorously controlled coating of the drug and polymer, whereby the drug is applied to a bare-metal stent in a dry powder, crystalline form. This preserves its morphology and optimizes its pharmacokinetic (distribution and absorption) profile. MiStent also leverages the benefits of a cobalt chromium coronary stent system -- a state-of-the-art, ultra-thin-strut metallic stent that has demonstrated excellent deliverability, conformability and flexibility. Dennis Donohoe, M.D., Micell's Chief Medical Advisor, remarked, "MiStent uniquely provides continued vascular drug delivery for nine months -- even after its bioresorbable polymer coating has been fully absorbed, which occurs over the course of 90 days." Dr. Donohoe continued, "Studies of MiStent to date have demonstrated a desirable lack of late lumen loss over 18 months, a characteristic that makes MiStent a clinically meaningful improvement in treating patients with coronary artery disease." About MiStent® MiStent is designed to optimize healing and clinical performance in patients with coronary artery disease. The rapidly absorbable coating of MiStent, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for extended local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents and improve long-term clinical outcomes. EU approval of MiStent was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Micell also completed enrollment in December 2015 of DESSOLVE III, a 1,400 patient, 20 center, randomized clinical trial comparing MiStent to Xience Everolimus Eluting Coronary Stent System® (Xience). DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent and Xience in a "real world, all-comers" patient population. Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome, and qualified for percutaneous coronary interventions. The primary endpoint for this trial is a non-inferiority comparison of target lesion failure (TLF) of the MiStent group versus the Xience group at 12 months post-procedure. The 12-month primary endpoint results for DESSOLVE III are expected to be released in the first half of 2017. MiStent has received CE marking, but is not approved for sale in the United States. Caution Regarding Forward-Looking Statements This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as "anticipates," "estimates," "expects," "projects," "intends," "plans," "believes" and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of MiStent in Europe and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of, and expectations about, future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to, the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent in other jurisdictions; the successful development and commercialization of MiStent in Europe and other markets; the ability of MiStent to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward-looking statement contained in this press release. Micell, Micell Technologies, the Micell Logo, MiStent and MiStent SES are among the trademarks of Micell Technologies, Inc.


News Article | October 31, 2016
Site: www.eurekalert.org

WASHINGTON - October 30, 2016 - The large multinational randomized BIONICS study found that a novel ridaforolimus-eluting stent (BioNIR) was non-inferior to a zotarolimus-eluting stent (Resolute) for one-year clinical outcomes in a broad, less selected 'more comers' population. Results of this trial will be submitted to the FDA for U.S. approval of this novel drug-eluting stent. Findings were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. The ridaforolimus-eluting stent is a thin-strut (90 μm) cobalt chromium stent that elutes the rapamycin analogue ridaforolimus from a durable elastomeric polymeric coating. The multicenter randomized trial was conducted at 76 medical centers in the U.S., Canada, Europe, and Israel and enrolled a broad range of patients with coronary artery disease including patients with Non-ST Elevation MI (NSTEMI) as well as complex lesions. The primary endpoint was target lesion failure (TLF) at one year, the composite rate of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia driven target lesion revascularization (ID-TLR). Secondary endpoints were one year major adverse cardiovascular events (MACE), target vessel failure (TVF) and individual component endpoints, definite/probable stent thrombosis and procedural success. A total of 1,919 patients were randomized 1:1 to the BioNIR ridaforolimus-eluting stent (n= 958, 1,275 lesions) or Resolute zotarolimus-eluting stent (n=961, 1,277 lesions) stent. The baseline clinical characteristics were well balanced between the two arms, as were angiographic baseline characteristics with the exception of severe calcification (13.3% in the BioNIR group vs. 10.5% in the Resolute group, P=0.03). The primary endpoint of TLF at one year was identical for both at 5.3% (P=0.98). In addition, the rates of cardiac death (0.5% vs. 0.2%, P=0.29), TV-MI (3.1% vs. 3.3%, P=0.81) and ID-TLR (3.0% vs. 2.4%, P=0.38) were similar. Definite/probable stent thrombosis was 0.4% (4/921) for the ridaforolimus-eluting stent and 0.6% (6/927) for the zotarolimus-eluting stent (P=0.75). Device success was 98.3% for the ridaforolimus-eluting compared to 99.5% for the zotarolimus-eluting stent (P=0.004). "One-year clinical outcomes from the BIONICS study clearly show that the ridaforolimus-eluting stent was non-inferior to the zotarolimus-eluting stent with identical target lesion failure rates," said principal investigator, David E. Kandzari, MD. Dr. Kandzari is Director of Interventional Cardiology and Chief Scientific Officer at the Piedmont Heart Institute in Atlanta, GA. "In addition, it had a low stent thrombosis rate with no events beyond 30 days." The BIONICS trial was funded by Medinol and designed and conducted by the CRF Clinical Trials Center in collaboration with Novella Clinical which provided site management. Dr. Kandzari reported grant or research support from Abbott Vascular, Boston Scientific, Medtronic, Biotronik, St. Jude Medical/Thoratec, and Ablative Solutions, and consulting fees/honoraria from Boston Scientific, Medtronic, Micell Technologies, and St. Jude Medical. The results of the BIONICS Trial will be presented on Sunday, October 30 at 9:40 AM ET in the Main Arena (Ballroom, Level 3) of the Walter E. Washington Convention Center. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .


Kandzari D.E.,Piedmont Heart Institute | Leon M.B.,Columbia University Medical Center | Meredith I.,Monash University | Fajadet J.,Clinique Pasteur | And 2 more authors.
JACC: Cardiovascular Interventions | Year: 2013

Objectives: The aim of this study was to evaluate late safety and efficacy outcomes among patients enrolled in clinical trials comparing Endeavor zotarolimus-eluting stents (E-ZES) (Medtronic, Inc., Santa Rosa, California) with first-generation drug-eluting stents (DES) and bare-metal stents (BMS). Background: Despite demonstration of higher angiographic luminal loss and restenosis with E-ZES compared with alternative DES, whether differences in these early angiographic measures translate into more disparate late clinical events is uncertain. Methods: Among 3,616 patients undergoing percutaneous coronary revascularization in 5 registration trials, late safety and efficacy events were compared between E-ZES (n = 2,132) versus sirolimus- or paclitaxel-eluting stents (n = 888) or BMS (n = 596). Results: Compared with a parallel cohort of patients treated with first-generation DES and BMS, 5-year rates of cardiac death/myocardial infarction (MI) (5.8% vs. 8.8% DES, p = 0.003; vs. 8.4% BMS, p = 0.02) and major adverse cardiac events (16.1% vs. 20.6% DES, p = 0.009; vs. 24.6% BMS, p < 0.001) were significantly lower with E-ZES. The E-ZES was associated with significantly lower target lesion revascularization (TLR) compared with BMS (7.4% vs. 16.3%, p < 0.001) but similar to comparator DES (7.4% vs. 8.1%, p = 0.63). Despite higher TLR in the first year with E-ZES compared with DES, between 1- and 5-year follow-up, rates of cardiac death/MI, TLR, and definite/probable stent thrombosis were significantly lower with E-ZES. Conclusions: Over 5 years, significant differences in cardiac death/MI and composite endpoints favored treatment with E-ZES over comparator BMS and DES. Rates of clinical restenosis and safety events, including stent thrombosis beyond the first year of revascularization, remain stable with E-ZES, leading to significant differences compared with first-generation DES. © 2013 American College of Cardiology Foundation.


Bhatt D.L.,Harvard University | Kandzari D.E.,Piedmont Heart Institute | O'Neill W.W.,Ford Motor Company | D'Agostino R.,Boston University | And 13 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. METHODS: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. RESULTS: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P = 0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P = 0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. CONCLUSIONS: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. Copyright © 2014 Massachusetts Medical Society.


The relationship between chest lateral width, tube current, image noise, and radiation exposure on 320-detector row CT has not been reported. We investigated the relationships between chest lateral width, estimated radiation exposure (DLPe), and image noise in 300 patients undergoing clinical coronary calcium scanning. Patients undergoing coronary calcium scanning with 320-detector row CT (prospective, volumetric mode, 120 kV of tube voltage, 100-550 mA of tube current, 0.5-mm detector width) were grouped by chest lateral width (small, medium, and large) from anteroposterior topograms and 100 consecutive patients were selected from each group (n = 300). Tube current, DLPe, and noise were compared among groups with Kruskal-Wallis or one-way ANOVA. Phantom experiments were performed to evaluate the accuracy of calcium quantification as a function of size and tube current. Median tube current in small, medium, and large patients was 130, 200, and 250 mA, respectively (P < 0.0001). Despite the use of higher tube current settings, noise levels also increased with size (20.2 ± 4.5 HU, 22.0 ± 3.9 HU, and 25.1 ± 4.9 HU, respectively; global P < 0.001). DLPe was significantly higher with increasing size (54, 83, and 104 mGy · cm, respectively; P < 0.0001). Phantom experiments showed that 50-100 mA, 150-200 mA, and approximately 300 mA in small, medium, and large phantoms were associated with stable estimate of calcium. Increasing chest lateral width is associated with increasing radiation exposure and image noise. The use of 50-100 mA in small and 150-200 mA in medium patients is associated with acceptable noise and stable estimate of coronary artery calcium. In large patients, precise identification of individual calcified lesions remains difficult despite increasing tube current and radiation exposure. Copyright © 2011 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.


Kandzari D.E.,Piedmont Heart Institute | Mauri L.,Harvard University | Popma J.J.,Beth Israel Deaconess Medical Center | Turco M.A.,Washington Adventist Hospital | And 3 more authors.
JACC: Cardiovascular Interventions | Year: 2011

Objectives: This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES). Background: Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events. Methods: Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss. Results: At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015). Conclusions: Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256). © 2011 American College of Cardiology Foundation.


Garbi M.,King's College | Chambers J.,Guys And St Thomas Hospital | Vannan M.A.,Piedmont Heart Institute | Lancellotti P.,University of Liège | Lancellotti P.,GVM Care and Research
JACC: Cardiovascular Imaging | Year: 2015

Valve stress echocardiography (VSE) is increasingly used both within specialist valve clinics and within dedicated VSE services, mandating practical guidance for referral, procedure, reporting, and clinical implementation of results. Therefore, a didactic VSE guide was compiled based on current European Society of Cardiology and American College of Cardiology/American Heart Association valve disease management guidelines, review of existing evidence, and the authors' extensive experience with VSE. The VSE indications were grouped into 3 categories: symptoms despite nonsevere valve disease, asymptomatic severe valve disease, and valve disease with reduced left ventricular systolic function. The aim of the test, the type of stress to be used, the sequence of image acquisition, the information to be included in the report, and the implication of the VSE results for clinical management were described for every indication and summarized in user-friendly tables. © 2015 American College of Cardiology Foundation.


Kosmidou I.,Piedmont Heart Institute
Journal of visualized experiments : JoVE | Year: 2013

Cryoballoon ablation (CBA) is an established therapy for atrial fibrillation (AF). Pulmonary vein (PV) occlusion is essential for achieving antral contact and PV isolation and is typically assessed by contrast injection. We present a novel method of direct pressure monitoring for assessment of PV occlusion. Transcatheter pressure is monitored during balloon advancement to the PV antrum. Pressure is recorded via a single pressure transducer connected to the inner lumen of the cryoballoon. Pressure curve characteristics are used to assess occlusion in conjunction with fluoroscopic or intracardiac echocardiography (ICE) guidance. PV occlusion is confirmed when loss of typical left atrial (LA) pressure waveform is observed with recordings of PA pressure characteristics (no A wave and rapid V wave upstroke). Complete pulmonary vein occlusion as assessed with this technique has been confirmed with concurrent contrast utilization during the initial testing of the technique and has been shown to be highly accurate and readily reproducible. We evaluated the efficacy of this novel technique in 35 patients. A total of 128 veins were assessed for occlusion with the cryoballoon utilizing the pressure monitoring technique; occlusive pressure was demonstrated in 113 veins with resultant successful pulmonary vein isolation in 111 veins (98.2%). Occlusion was confirmed with subsequent contrast injection during the initial ten procedures, after which contrast utilization was rapidly reduced or eliminated given the highly accurate identification of occlusive pressure waveform with limited initial training. Verification of PV occlusive pressure during CBA is a novel approach to assessing effective PV occlusion and it accurately predicts electrical isolation. Utilization of this method results in significant decrease in fluoroscopy time and volume of contrast.


News Article | December 16, 2016
Site: www.gizmag.com

Researchers at Georgia Tech are 3D printing replicas of patients' heart valves, in order to match them with the perfect prosthetic(Credit: Rob Felt, Georgia Tech) Although fully-functional 3D printed organs might still be a ways down the track, the technology has been saving lives for years by creating tissue, lifelike training models and external devices that mimic organ function. Now a team at Georgia Tech is 3D printing exact replicas of patients' heart valves, based on details pulled from CT scans, to help pick out the perfect prosthetic. While similar systems could help with a range of illnesses, the study has been focused on helping surgeons treat aortic stenosis, a condition where the left ventricle constricts and causes the heart to work harder to pump blood through. If left untreated, it can eventually lead to complications as severe as heart failure. One alternative to open-heart surgery is a procedure known as transcatheter aortic valve replacement (TAVR), which allows the surgeon to repair the valve without actually removing it. Since it can be performed through smaller openings that don't require separation of the ribs, it's far less invasive and is a preferred option for patients, particularly the elderly, who may be vulnerable to complications from the more extreme procedure. To account for the natural variations in patients of different body types, sexes and ages, the prosthetic valves are available in a range of types and sizes, and finding one that's a perfect match for a patient is extremely important to keep blood from leaking around the implant. Enter Georgia Tech's 3D printed model. Created using data from a CT scan of the person's own valve, doctors can inspect the model freely and match up the right prosthetic before they ever pick up a scalpel. "The issue is, everybody is different," says Chuck Zhang, a Georgia Tech professor. "A male will be different than a female. It's a big challenge for the doctors to select the right type of that prosthesis for a specific patient." Using a multi-material 3D printer, the researchers can tweak details to create an exact copy of the natural valve that moves, feels and stretches like the real thing. It's even able to recreate related conditions specific to a patient, like deposits of calcium that may be present, to aid in deciding which implant is the best fit. "The results are quite encouraging," says Zhen Qian, of the Piedmont Heart Institute, a partner on the project. "Our printed model is able to tell you before the procedure how much paravalvular leakage there will be and where it is, a good indicator for short- and long-term mortality." So far, the team has printed heart models based on data from more than 20 patients, but has yet to begin using them for pre-surgery planning. That's the next step, along with imaging patients that have already undergone a TAVR procedure to help determine just how effective their models are at matching patients with prosthetics. "There is big potential for these models," says Zhang. "We're thinking in the future, this may be a standard tool for pre-surgery planning and for training new surgeons." Eventually, the models could be made with embedded sensors in the valve walls, to better monitor the effects of a prosthetic on the surrounding tissue.

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