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1.
Catheter Cardiovasc Interv ; 100(5): 776-784, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36129818

RESUMO

BACKGROUND: The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. METHODS: We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. RESULTS: There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). CONCLUSION: In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.


Assuntos
Artéria Femoral , Dispositivos de Oclusão Vascular , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Artéria Femoral/diagnóstico por imagem , Dispositivos de Oclusão Vascular/efeitos adversos , Técnicas Hemostáticas/efeitos adversos , Punções , Resultado do Tratamento
2.
J Cardiovasc Electrophysiol ; 31(12): 3117-3123, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33022816

RESUMO

OBJECTIVE: To compare multiple-procedure catheter ablation outcomes of a stepwise approach versus left atrial posterior wall isolation (LA PWI) in patients undergoing nonparoxysmal atrial fibrillation (NPAF) ablation. BACKGROUND: Unfavorable outcomes for stepwise ablation of NPAF in large clinical trials may be attributable to proarrhythmic effects of incomplete ablation lines. It is unknown if a more extensive initial ablation strategy results in improved outcomes following multiple ablation procedures. METHODS: Two hundred twenty two consecutive patients with NPAF underwent first-time ablation using a contact-force sensing ablation catheter utilizing either a stepwise (Group 1, n = 111) or LA PWI (Group 2, n = 111) approach. The duration of follow-up was 36 months. The primary endpoint was freedom from atrial arrhythmia >30 s. Secondary endpoints were freedom from persistent arrhythmia, repeat ablation, and recurrent arrhythmia after repeat ablation. RESULTS: There was similar freedom from atrial arrhythmias after index ablation for both stepwise and LA PWI groups at 36 months (60% vs. 69%, p = .1). The stepwise group was more likely to present with persistent recurrent arrhythmia (29% vs. 14%, p = .005) and more likely to undergo second catheter ablation (32% vs. 12%, p < .001) compared to LA PWI patients. Recurrent arrhythmia after repeat ablation was more likely in the stepwise group compared to the LA PWI group (15% vs. 4%, p = .003). CONCLUSIONS: Compared to a stepwise approach, LA PWI for patients with NPAF resulted in a similar incidence of any atrial arrhythmia, lower incidence of persistent arrhythmia, and fewer repeat ablations. Results for repeat ablation were not improved with a more extensive initial approach.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Átrios do Coração/diagnóstico por imagem , Átrios do Coração/cirurgia , Humanos , Veias Pulmonares/cirurgia , Recidiva , Resultado do Tratamento
3.
Pacing Clin Electrophysiol ; 43(4): 382-387, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32144936

RESUMO

BACKGROUND: Managing elderly patients with infection or malfunction deriving from a cardiac implantable electronic device (CIED) may be challenging. The aim of this study was to evaluate safety and efficacy of mechanical transvenous lead extraction (TLE) in elderly patients. METHODS: Patients who had undergone TLE in single tertiary referral center were divided in two groups (group 1: ≥ 80 years; group 2: < 80 years) and their acute and chronic outcomes were compared. All patients were treated with manual traction or mechanical dilatation. RESULTS: Our analysis included 1316 patients (group 1: 202; group 2: 1114 patients), with a total of 2513 leads extracted. Group 1 presented more comorbidities, more pacemakers than implantable cardioverter-defibrillators, whereas the dwelling time of the oldest lead and the number of leads were similar, irrespective of patient's age. In group 1, the radiological success rate for lead was higher (99.0% vs 95.9%; P < .001) and the fluoroscopy time lower (13.0 vs 15.0 min; P = .04) than in group 2. Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P = .36). Major complications occurred in 10 patients (0.7%) without significative differences between patients with more or less than 80 years (group 1: 1.5% vs group 2: 0.6%; P = .24) and with no procedure-related deaths in elderly group. CONCLUSIONS: Mechanical TLE in elderly patients is a safe and effective procedure. In the over-80s, a comparable incidence of major complications with younger patients was observed, with at least a similar efficacy of the procedure.


Assuntos
Desfibriladores Implantáveis , Remoção de Dispositivo/métodos , Marca-Passo Artificial , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Remoção de Dispositivo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Resultado do Tratamento
4.
Heart Rhythm ; 2024 May 19.
Artigo em Inglês | MEDLINE | ID: mdl-38768839

RESUMO

BACKGROUND: The safety and long-term efficacy of radiofrequency (RF) catheter ablation (CA) of paroxysmal atrial fibrillation (PAF) has been well established. Contemporary techniques to optimize ablation delivery, reduce fluoroscopy use, and improve clinical outcomes have been developed. OBJECTIVE: The purpose of this study was to assess the contemporary real-world practice approach and short and long-term outcomes of RF CA for PAF through a prospective multicenter registry. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation; ClincalTrials.gov Identifier: NCT04088071) Registry, patients undergoing RF CA to treat PAF across 42 high-volume institutions and 79 experienced operators were evaluated. The procedures were performed using zero or reduced fluoroscopy, contact force sensing catheters, wide area circumferential ablation, and ablation index as a guide with a target of 380-420 for posterior and 500-550 for anterior lesions. The primary efficacy outcome was freedom from all-atrial arrhythmia recurrence at 12 months. RESULTS: A total of 2470 patients undergoing CA from January 2018 to December 2022 were included. Mean age was 65.2 ±11.14 years, and 44% were female. Most procedures were performed without fluoroscopy (71.5%), with average procedural and total RF times of 95.4 ± 41.7 minutes and 22.1±11.8 minutes, respectively. At 1-year follow-up, freedom from all-atrial arrhythmias was 81.6% with 89.7% of these patients off antiarrhythmic drugs. No significant difference was identified comparing pulmonary vein isolation vs pulmonary vein isolation plus ablation approaches. The complication rate was 1.9%. CONCLUSION: Refinement of RF CA to treat PAF using contemporary tools, standardized protocols, and electrophysiology laboratory workflows resulted in excellent short- and long-term clinical outcomes.

5.
J Pharm Bioallied Sci ; 16(Suppl 1): S859-S861, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38595409

RESUMO

Introduction: Oral soft lesions represent a diverse array of pathological conditions that necessitate precise and effective treatment. Laser-assisted excision has gained prominence due to its purported benefits in terms of reduced procedural time, decreased bleeding, and improved aesthetic outcomes. However, conventional excision remains a common practice. Materials and Methods: A total of 100 patients with clinically diagnosed oral soft lesions were enrolled in this prospective study. The patients were randomly divided into two groups: the laser-assisted excision group and the conventional excision group. Demographics, lesion characteristics, and medical histories were recorded for each patient. Procedural parameters such as operative time and intraoperative bleeding were meticulously documented. Results: The laser-assisted excision group exhibited a statistically significant reduction in procedural duration compared to the conventional excision group (P < 0.05), with mean operative times of 15.2 and 20.8 min, respectively. Intraoperative bleeding was significantly reduced in the laser-assisted group (P < 0.01), with an average blood loss of 15.7 ml, while the conventional excision group reported an average blood loss of 28.6 ml. Postoperative complications analysis demonstrated that the laser-assisted group had a lower incidence of wound infections (P < 0.05) compared to the conventional excision group (5% vs. 15%). Additionally, the laser-assisted group exhibited significantly reduced scarring (P < 0.01) as reported by both patients and clinicians. Patient satisfaction scores were consistently higher in the laser-assisted excision group, with 85% of patients reporting contentment with the procedure, in contrast to 65% in the conventional excision group. Conclusion: In light of the results obtained from this study, laser-assisted excision emerges as a favorable approach for the management of oral soft lesions.

6.
Am J Cardiol ; 226: 59-64, 2024 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-38945347

RESUMO

Radial artery (RA) access has been increasingly utilized for coronary procedures because of lower rates of access-site complications and improved patient satisfaction. However, limited data are available for RA access for peripheral vascular intervention (PVI). We performed a retrospective review of 143 patients who underwent PVI through RA access from February 2020 to September 2022 at a single institution. Baseline characteristics and follow-up data were ascertained from a prospectively maintained institutional database. Of 491 PVI, 156 (31.8%) were performed through the RA. Anatomical locations for intervention were the femoral (44.8%), iliac (31.1%), popliteal (9.6%) peroneal (2.7%), tibial (9.9%), and subclavian (1.9%) arteries. Procedural access was obtained through the right RA (92.9%), left RA (4.5%), or right ulnar artery (2.6%) using the 6 French R2P Destination Slender sheath in 85, 105, and 119 cm lengths. Atherectomy was used in 34.7%. Mean contrast volume was 105.5 ml and the average fluoroscopy time was 18.5 minutes. Conversion to femoral access occurred in 3 cases (1.9%) because of arterial spasm and noncrossable lesions. Concomitant pedal access occurred in 2 cases (1.3%). Periprocedural complication rate was 3.84%, of which access-site hematoma was most common (3.2%); none required blood transfusion, surgical intervention, or additional hospital stay. There was 1 case (0.64%) of in-hospital stroke. The mortality rate at 30-day, 6-month, and 1-year was 1.4%, 2.8%, and 4.2%, respectively. In conclusion, RA access is feasible for diverse PVI, and future studies are needed to assess safety and benefit compared with femoral artery access.


Assuntos
Artéria Radial , Humanos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Pessoa de Meia-Idade , Cateterismo Periférico/métodos , Artéria Femoral , Procedimentos Endovasculares/métodos , Aterectomia/métodos , Resultado do Tratamento , Doença Arterial Periférica/cirurgia
7.
Int J Numer Method Biomed Eng ; 39(3): e3685, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36645263

RESUMO

The purpose of this work is to present a patient-specific (PS) modeling approach for simulating percutaneous transluminal angioplasty (PTA) endovascular treatment and assessing the balloon sizing influence on short-term outcomes in peripheral arteries, i.e. without stent implantation. Two 3D PS stenosed femoral artery models, one with a dominant calcified atherosclerosis while the other with a lipidic plaque, were generated from pre-operative computed tomography angiography images. Elastoplastic constitutive laws were implemented within the plaque and artery models. Implicit finite element method (FEM) was used to simulate the balloon inflation and deflation for different sizings. Besides vessel strains, results were mainly evaluated in terms of the elastic recoil ratio (ERR) and lumen gain ratio (LGR) attained immediately after PTA. Higher LGR values were shown within the stenosed region of the lipidic patient. Simulated results also showed a direct and quantified correlation between balloon sizing and LGR and ERR for both patients after PTA, with a more significant influence on the lumen gain. The max principal strain values in the outer arterial wall increased at higher balloon sizes during inflation as well, with higher rates of increase when the plaque was calcified. Results show that our model could serve in finding a compromise for each stenosis type: maximizing the achieved lumen gain after PTA, but at the same time without damaging the arterial tissue. The proposed methodology can serve as a step toward a clinical decision support system to improve angioplasty balloon sizing selection prior to the surgery.


Assuntos
Angioplastia com Balão , Angioplastia , Humanos , Análise de Elementos Finitos , Angioplastia/métodos , Artéria Femoral/cirurgia , Constrição Patológica , Stents , Resultado do Tratamento
8.
J Interv Card Electrophysiol ; 63(1): 97-101, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33543350

RESUMO

PURPOSE: Catheter ablation procedures for atrial fibrillation (AF) were significantly curtailed during the peak of coronavirus disease 2019 (COVID-19) pandemic to conserve healthcare resources and limit exposure. There is little data regarding peri-procedural outcomes of medical procedures during the COVID-19 pandemic. We enacted protocols to safely reboot AF ablation while limiting healthcare resource utilization. We aimed to evaluate acute and subacute outcomes of protocols instituted for reboot of AF ablation during the COVID-19 pandemic. METHODS: Perioperative healthcare utilization and acute procedural outcomes were analyzed for consecutive patients undergoing AF ablation under COVID-19 protocols (2020 cohort; n=111) and compared to those of patients who underwent AF ablation during the same time period in 2019 (2019 cohort; n=200). Newly implemented practices included preoperative COVID-19 testing, selective transesophageal echocardiography (TEE), utilization of venous closure, and same-day discharge when clinically appropriate. RESULTS: Pre-ablation COVID-19 testing was positive in 1 of 111 patients. There were 0 cases ablation-related COVID-19 transmission and 0 major complications in either cohort. Pre-procedure TEE was performed in significantly fewer 2020 cohort patients compared to the 2019 cohort patients (68.4% vs. 97.5%, p <0.001, respectively) despite greater prevalence of persistent arrhythmia in the 2020 cohort. Same-day discharge was achieved in 68% of patients in the 2020 cohort, compared to 0% of patients in the 2019 cohort. CONCLUSIONS: Our findings demonstrate the feasibility of safe resumption of complex electrophysiology procedures during the COVID-19 pandemic, reducing healthcare utilization and maintaining quality of care. Protocols instituted may be generalizable to other types of procedures and settings.


Assuntos
Fibrilação Atrial , COVID-19 , Ablação por Cateter , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Teste para COVID-19 , Humanos , Pandemias , SARS-CoV-2 , Resultado do Tratamento
9.
Cardiovasc Revasc Med ; 45: 3-8, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35995656

RESUMO

BACKGROUND: Mixed reality head-mounted displays (MR-HMD) are a novel and emerging tool in healthcare. There is a paucity of data on the safety and efficacy of the use of MR-HMD in the cardiac catheterization laboratory (CCL). We sought to analyze and compare fluoroscopy time, procedure time, and complication rates with right heart catheterizations (RHCs) and coronary angiographies (CAs) performed with MR-HMD versus standard LCD medical displays. METHODS: This is a non-randomized trial that included patients who underwent RHC and CA with MR-HMD between August 2019 and January 2020. Their outcomes were compared to a control group during the same time period. The primary endpoints were procedure time, fluoroscopy time, and dose area product (DAP). The secondary endpoints were contrast volume and intra and postprocedural complications rate. RESULTS: 50 patients were enrolled in the trial, 33 had a RHC done, and 29 had a diagnostic CA performed. They were compared to 232 patients in the control group. The use of MR-HMD was associated with a significantly lower procedure time (20 min (IQR 14-30) vs. 25 min (IQR 18-36), p = 0.038). There were no significant differences in median fluoroscopy time (1.5 min (IQR 0.7-4.9) in the study group vs. 1.3 min (IQR 0.8-3.1), p = 0.84) or median DAP (165.4 mGy·cm2 (IQR 13-15,583) in the study group vs. 913 mGy·cm2 (IQR 24-6291), p = 0.17). There was no significant increase in intra- or post-procedure complications. CONCLUSION: MR-HMD use is safe and feasible and may decrease procedure time in the CCL.


Assuntos
Realidade Aumentada , Cateterismo Cardíaco , Humanos , Fluoroscopia
10.
Int J Numer Method Biomed Eng ; 37(8): e3499, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33998779

RESUMO

In this work we propose a generic modeling approach for simulating percutaneous transluminal angioplasty (PTA) endovascular treatment, and evaluating the influence of balloon design, plaque composition, and balloon sizing on acute post-procedural outcomes right after PTA, without stent implantation. Clinically-used PTA balloons were classified into two categories according to their compliance characteristics, and were modeled correspondingly. Self-defined elastoplastic constitutive laws were implemented within the plaque and artery models, after calibration based on experimental and clinical data. Finite element method (FEM) implicit solver was used to simulate balloon inflation and deflation. Besides balloon profile at max inflation, results are mainly assessed in terms of the elastic recoil ratio (ERR) and lumen gain ratio (LGR) obtained immediately after PTA. No variations in ERR nor LGR values were detected when the balloon design changed, despite the differences observed in their profile at max inflation. Moreover, LGR and ERR inversely varied with the augmentation of calcification level within the plaque (-11% vs. +4% respectively, from fully lipidic to fully calcified plaque). Furthermore, results showed a direct correlation between balloon sizing and LGR and ERR, with noticeably higher rates of change for LGR (+18% and +2% for LGR and ERR respectively for a calcified plaque and a balloon pressure increasing from 10 to 14 atm). However a larger LGR comes with a higher risk of arterial rupture. This proposed methodology opens the way for evaluation of angioplasty balloon selections towards clinical procedure optimization.


Assuntos
Angioplastia com Balão , Placa Aterosclerótica , Angioplastia , Análise de Elementos Finitos , Humanos , Placa Aterosclerótica/terapia , Resultado do Tratamento
11.
J Interv Card Electrophysiol ; 58(1): 69-75, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31707533

RESUMO

INTRODUCTION: Clinical trials have failed to reliably show improved outcomes with utilization of contact-force sensing (CFS) radiofrequency (RF) ablation catheters. It is unknown whether the unfavorable outcomes observed in these trials are attributable to inexperience with CFS technology. OBJECTIVES: To compare catheter ablation outcomes of stepwise linear ablation with versus without CFS technology and to assess the impact of operator experience with CFS technology on procedural outcomes. METHODS: Clinical outcomes were evaluated in 228 consecutive NPAF patients undergoing first-time left atrial ablation using a stepwise linear approach. Arrhythmia recurrence was assessed using 2-week event monitors at 3-month intervals following index ablation. RESULTS: A total of 228 patients were included in our study. There was no statistically significant difference in risk of recurrent atrial arrhythmias at 12 and 24 months between CFS and non-CFS patients (p = 0.5 and p = 0.169). The time to recurrence of atrial arrhythmias at 24 months in the second half of CFS patients was significantly lower when compared to both the first half of CFS patients (p = 0.002) and non-CFS patients (p = 0.005). CONCLUSION: While there was no difference in overall outcomes between CFS and non-CFS ablation using a stepwise linear approach in patients with NPAF, procedural efficacy of the second half of CFS patients was significantly improved compared to both the first half of CFS patients and all non-CFS patients. Lack of benefit seen in clinical trials using CFS technology may be related to operator inexperience with CFS ablation catheters at the time of the trials.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Átrios do Coração , Humanos , Veias Pulmonares/cirurgia , Recidiva , Resultado do Tratamento
13.
Accid Anal Prev ; 117: 121-127, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29698865

RESUMO

INTRODUCTION: This study evaluates the impact of moped crashes in North Carolina, a state with lenient moped legislation by(1) describing the characteristics of moped crashes and (2) estimating the cost burden of moped-related injuries. METHODS: Health and public records of moped crash subjects treated at our hospital were reviewed. Direct costs were billed hospital charges. Indirect costs based on age and outcomes were calculated. RESULTS: Between 2008-2013, 368 subjects were involved in 373 moped crashes. 52% of drivers were intoxicated. 38% of drivers had prior DWIs and 26% had prior revoked licenses. Hospitalized subjects (n = 305) had a combined 2687 hospital days, 695 ICU days and 449 trips to the operating room for treatment of their injuries. Average hospital charges were $70,561 per subject. Total direct and indirect costs of moped injuries were over $26 million and $81 million respectively. Medicaid absorbed most of the direct cost ($13.7 M). Estimated direct cost of moped crashes across the state totaled $133 million. CONCLUSION: Healthcare and financial ramifications of moped collisions are substantial. Laws governing moped drivers and stricter penalties for intoxicated drivers are needed.


Assuntos
Acidentes de Trânsito/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Hospitalização/economia , Motocicletas/legislação & jurisprudência , Ferimentos e Lesões , Acidentes de Trânsito/classificação , Acidentes de Trânsito/economia , Adolescente , Adulto , Dirigir sob a Influência/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Motocicletas/economia , Motocicletas/estatística & dados numéricos , North Carolina/epidemiologia , Ferimentos e Lesões/economia , Ferimentos e Lesões/epidemiologia
14.
J Invasive Cardiol ; 30(9): 324-328, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29906265

RESUMO

BACKGROUND: Transcatheter mitral valve-in-valve (TMVIV) or valve-in-ring (TMVIR) replacement has shown early promise in patients deemed poor surgical candidates as a less invasive alternative to conventional reoperative mitral valve (MV) replacement. OBJECTIVE: This retrospective, single-center study reviewed the procedural outcomes of all TMVIV and TMVIR procedures between 2013-2018 at a large tertiary referral center serving the southeastern United States. An analysis of patient safety measures was also performed, with a retrospective assessment of relative procedural safety that included preoperative risk stratification and postoperative mortality predictors, operative time, average blood loss, length of hospital stay, and readmission rates. METHODS: This study included 24 patients with severe MV disease and medical comorbidities who were considered too high risk for conventional MV replacement. All patients underwent TMVIV or TMVIR with Edwards Sapien XT or S3 transcatheter valves (Edwards Lifesciences). A secure database of patient demographics, preoperative risk assessment, and procedural data was created and included technical success rates, blood loss, operative time, and intraoperative and immediate postoperative complications. Subsequent follow-up of patient outcomes reported here include those collected at 30 days, 180 days, and 1 year. RESULTS: Of the 24 patients in our study, 16 received TMVIV and 8 received TMVIR implantation. Each procedure was performed successfully under general anesthesia via transseptal approach (n = 17) or transapical approach (n = 7), with only 1 patient (8.2%) requiring late operative reintervention 252 days post op. Average procedural time was 76 min and average blood loss was <75 mL, with 20/24 patients (83%) successfully extubated on postoperative day 0. Length of Intensive Care Unit stay was 1.7 ± 1.4 days and length of total inpatient stay was 2.8 ± 1.8 days. Echocardiograms were collected immediately post op, at 30 days, at 180 days, and subsequently at yearly intervals; follow-up demonstrated excellent prosthetic valve function with low transvalvular gradients, and no evidence of valve embolization or thrombosis. In patients with follow-up data available at 1 year (n = 13), there were no readmissions at 30 days or 180 days, and only 1 admission (8.3%) during the first postoperative year for symptoms related to congestive heart failure (CHF). CONCLUSION: TMVIV and TMVIR can be safe and effective in a patient population considered at prohibitive risk for conventional surgery. These procedures can be performed efficiently in a hybrid operating room, with relatively short procedural times and high rates of early extubation. Procedural complications, mortality, and readmission rates for CHF at 30 days, 180 days, and 1 year were very low in this high-risk cohort.


Assuntos
Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Medição de Risco , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Reoperação , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
15.
J Am Coll Cardiol ; 69(10): 1215-1230, 2017 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-27956264

RESUMO

BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services. OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry. RESULTS: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%. CONCLUSIONS: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.


Assuntos
Cateterismo Cardíaco , Cardiologia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/estatística & dados numéricos , Sistema de Registros , Sociedades Médicas , Cirurgia Torácica , Congressos como Assunto , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Estados Unidos
16.
Eur J Cardiothorac Surg ; 44(5): 898-904, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23435523

RESUMO

OBJECTIVES: Endoaortic balloon occlusion (EBO) and aortic transthoracic clamping (TTC) are the dominant methods of remote access perfusion (RAP) in minimally invasive cardiac surgery. The aim of the study was to compare the two methods in terms of feasibility, success and complications. METHODS: From June 2001 to November 2011, 307 (median age; range) (57; 16-77 years) and 460 (62; 11-88 years) patients underwent minimally invasive CABG, ASD and mitral valve surgery using EBO and TTC, respectively. Perioperative procedure feasibility, success and postoperative complications were recorded. RESULTS: Overall 30-day mortality was 0 and 2 (0.43%) for the EBO and TTC groups, respectively (P = 0.52). Overall and RAP-associated conversions were noted in 21 (6.8%) and 4 (1.3%) patients in the EBO and in 9 (2%) and 6 (1.3%) patients in the TTC groups (P < 0.001, P = 1.00, respectively). Incidence of major complications, including aortic dissection, major vessel perforation, injury of intrapericardial structures, limb ischaemia, myocardial infarction and neurologic events, was similar [EBO: 12 (4%); TTC: 11 (2.4%); P = 0.23]. Minor complications such as minor vessel injury, groin bleeding or lymphatic fistula were noted in 31 (10.1%) and 35 (7.6%), respectively (P = 0.23). Successful RAP procedures defined as absence of RAP-associated conversions and major complications were equal [EBO: 295 (96%); TTC: 449 (97.6%); P = 0.23]. Complications detected during follow-up included pain: 30 of 249 (12%) and 13 of 279 (4.7%) (P = 0.002); sensational disturbances: 60 of 249 (24.1%) and 40 of 278 (14.4%) (P = 0.005) and wound-healing complications: 49 of 249 (19.7%) and 42 of 277 (15.2%) (P = 0.172) for EBO and TTC, respectively. CONCLUSIONS: RAP can be successfully and safely implemented in minimally invasive cardiac surgery. EBO and transthoracic clamping of the ascending aorta are performing equally in terms of feasibility and procedural success.


Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Reperfusão Miocárdica/efeitos adversos , Reperfusão Miocárdica/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Cardíacos/métodos , Ponte Cardiopulmonar/efeitos adversos , Ponte Cardiopulmonar/métodos , Criança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Período Perioperatório , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
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