Subject(s)
Cardiac Catheterization , Echocardiography, Three-Dimensional , Mitral Valve , Tomography, X-Ray Computed , Humans , Echocardiography, Three-Dimensional/methods , Cardiac Catheterization/methods , Tomography, X-Ray Computed/methods , Mitral Valve/diagnostic imaging , Female , Male , Aged , Reproducibility of Results , Echocardiography/methodsABSTRACT
BACKGROUND: Atherectomy use in treatment of femoropopliteal disease has significantly increased despite scant evidence of benefit to long-term clinical outcomes. AIMS: We investigated the clinical benefits of atherectomy over standard treatment for femoropopliteal interventions. METHODS: Using data from the Society of Vascular Surgery's Vascular Quality Initiative (VQI) registry, we identified patients who underwent isolated femoropopliteal interventions for occlusive disease. We compared 13,423 patients treated with atherectomy with 47,371 receiving standard treatment; both groups were allowed definitive treatment with a drug-coated balloon or stenting. The primary endpoint was major adverse limb events (MALEs), which is a composite of target vessel re-occlusion, ipsilateral major amputation, and target vessel revascularization. RESULTS: Mean age was 69 ± 11 years, and patients were followed for a median of 30 months. Overall rates of complications were slightly higher in the atherectomy group than the standard treatment group (6.2% vs. 5.9%, p < 0.0001). In multivariable analysis, after adjusting for demographic and clinical covariates, atherectomy use was associated with a 13% reduction in risk of MALEs (adjusted odds ratio [aOR]: 0.87; 95% confidence interval [CI]: 0.77-0.98). Rates of major and minor amputations were significantly lower in the atherectomy group (3.2% vs. 4.6% and 3.3% vs. 4.3%, respectively, both p < 0.001), primarily driven by a significantly decreased risk of major amputations (aOR 0.69; 95% CI: 0.52-0.91). There were no differences in 30-day mortality, primary patency, and target vessel revascularization between the atherectomy and standard treatment groups. CONCLUSIONS: In adults undergoing femoropopliteal interventions, the use of atherectomy was associated with a reduction in MALEs compared with standard treatment.
Subject(s)
Angioplasty, Balloon , Peripheral Arterial Disease , Male , Humans , Middle Aged , Aged , Aged, 80 and over , Femoral Artery/diagnostic imaging , Popliteal Artery/diagnostic imaging , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Angioplasty, Balloon/adverse effects , Treatment Outcome , Atherectomy/adverse effects , Registries , Vascular Patency , Risk FactorsABSTRACT
Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.
Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Male , Aged , Aged, 80 and over , Female , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Follow-Up Studies , Constriction, Pathologic/etiology , Constriction, Pathologic/surgery , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/etiology , Treatment Outcome , Transcatheter Aortic Valve Replacement/adverse effects , Surgical Instruments , Prosthesis Design , Risk FactorsABSTRACT
Background Although sex disparities in the diagnostic evaluation and revascularization of patients with acute myocardial infarction are well documented, no study has evaluated longitudinal trends in these disparities. Methods and Results Using the National Inpatient Sample from 2005 to 2019, 9 259 932 patients with acute myocardial infarction were identified. We divided 15 years into five 3-year periods. The primary objective was to evaluate sex-based trends in the use of diagnostic angiography, percutaneous coronary intervention, and coronary artery bypass graft (CABG) among patients with non-ST-segment-elevation myocardial infarction and ST-segment-elevation myocardial infarction (STEMI) over 15 years. The secondary objective was to evaluate sex disparities in mortality, length of stay, and cost. For non-ST-segment-elevation myocardial infarction, we saw a small reduction in sex disparity in the use of all diagnostic angiography in period 5 versus period 1 (4% versus 5.3%; P<0.01), no change in sex disparity in percutaneous coronary intervention use in period 5 versus period 1 (5.6% versus 5%; P=0.16), and a widening sex disparity in CABG in period 5 versus period 1 (5.4% versus 4.4%; P<0.01). However, we noted decreasing sex disparities in the use of diagnostic angiography, percutaneous coronary intervention, and CABG for ST-segment-elevation myocardial infarction in mostly all periods compared with period 1 (P<0.05, all comparisons), but differences still existed in period 5. Risk-adjusted in-hospital mortality was higher after CABG for non-ST-segment-elevation myocardial infarction and after percutaneous coronary intervention and CABG for ST-segment-elevation myocardial infarction in women than men. Conclusions Despite variable trends in sex disparities in diagnostic and revascularization procedures for acute myocardial infarction, disparities still exist.
Subject(s)
Myocardial Infarction , Percutaneous Coronary Intervention , Female , Humans , Male , Coronary Artery Bypass , Myocardial Infarction/diagnosis , Non-ST Elevated Myocardial Infarction/diagnosis , Non-ST Elevated Myocardial Infarction/surgery , Risk Factors , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/surgery , Time Factors , Treatment Outcome , Sex Factors , Acute DiseaseABSTRACT
Calcified aortic stenosis has become the most common form of acquired valvular heart disease in very old patients. Despite this fact, a majority of these patients were turned down by surgery owing to a risk of mortality > 10% in patients older than 90 years. In recent years, transcatheter aortic valve implantation (TAVI) has emerged as a therapeutic option for severe aortic stenosis. However, there is a paucity of data regarding the outcomes of TAVI in patients older than 100 years. We present the oldest patient who has undergone successful TAVI reported in the current literature.
ABSTRACT
BACKGROUND: Left ventricular (LV) mechanics are impaired in patients with severe aortic stenosis (AS). We hypothesized that there would be differences in myocardial mechanics, measured by global longitudinal strain (GLS) recovery in patients with four subtypes of severe AS after transcatheter aortic valve replacement (TAVR), stratified based upon flow and gradient. METHODS: We retrospectively evaluated 204 patients with severe AS who underwent TAVR and were followed post-TAVR at our institution for clinical outcomes. Speckle-tracking transthoracic echocardiography was performed pre- and post-TAVR. Patients were classified as: (1) normal-flow and high-gradient, (2) normal-flow and high-gradient with reduced LV ejection fraction (LVEF), (3) classical low-flow and low-gradient, or (4) paradoxical low-flow and low-gradient. RESULTS: Both GLS (-13.9 ± 4.3 to -14.8 ± 4.3, P < 0.0001) and LVEF (55 ± 15 to 57 ± 14%, P = 0.0001) improved immediately post-TAVR. Patients with low-flow AS had similar improvements in LVEF (+2.6 ± 9%) and aortic valve mean gradient (-23.95 ± 8.34 mmHg) as patients with normal-flow AS. GLS was significantly improved in patients with normal-flow (-0.93 ± 3.10, P = 0.0004) compared to low-flow AS. Across all types of AS, improvement in GLS was associated with a survival benefit, with GLS recovery in alive patients (mean GLS improvement of -1.07 ± 3.10, P < 0.0001). CONCLUSIONS: LV mechanics are abnormal in all patients with subtypes of severe AS and improve immediately post-TAVR. Recovery of GLS was associated with a survival benefit. Patients with both types of low-flow AS showed significantly improved, but still impaired, GLS post-TAVR, suggesting underlying myopathy that does not correct post-TAVR.
ABSTRACT
CoreValve is widely used in transcatheter aortic valve replacement, but the impact of its deployment location on hemodynamics is unexplored despite a potential role in subsequent aortic and coronary artery pathologies. The objectives of this investigation were to perform fluid-structure interaction (FSI) simulations for a 29â¯mm CoreValve deployed in annular vs supra-annular locations, and characterize resulting hemodynamics including velocity and wall shear stress (WSS). Patient-specific geometry was reconstructed from computed tomography scans and CoreValve was deployed using a finite element approach. FSI simulations were then performed using a boundary conforming method and realistic boundary conditions. Results showed that CoreValve deployment location impacts hemodynamics in the ascending aorta and flow patterns in the coronary arteries. During peak-systole, annularly deployed CoreValve produced a jet-like flow structure impinging on the outer-curvature of the ascending aorta. Supra-annularly deployed CoreValve having a lateral tilt of 10° led to a more centered jet impinging further downstream. At mid-systole, valve leaflets of the annularly deployed CoreValve closed asymmetrically leading to disorganized flow patterns in the ascending aorta vs those from the supra-annular position. Supra-annularly deployed CoreValve also led to high-velocity para-valvular flow supplying the coronary arteries. CoreValve in the supra-annular position significantly (Pâ¯<â¯0.05) elevated WSS within the first few diameters of both coronary arteries as compared to the annular position for many time points quantified. These results afforded by the advanced simulation methods may have important clinical implications given the role of aortic hemodynamics in dilation and the pro-atherogenic nature of WSS alterations in the coronary arteries.
Subject(s)
Aorta/physiology , Coronary Vessels/physiology , Heart Valve Prosthesis , Hemodynamics , Finite Element Analysis , Humans , Patient-Specific ModelingABSTRACT
Importance: Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur. Objective: To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR. Design, Setting, and Participants: The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017. Interventions: Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305). Main Outcomes and Measures: The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set. Results: Among 912 randomized patients (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, -∞ to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, -10.1%; Farrington-Manning 97.5% CI, -∞ to -4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, -6.1%; 95% CI, -9.6% to -2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, -10.2%; 95% CI, -16.3% to -4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%). Conclusions and Relevance: Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02202434.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Bioprosthesis , Cardiovascular Diseases/etiology , Cardiovascular Diseases/mortality , Female , Follow-Up Studies , Humans , Male , Postoperative Complications/etiology , Prosthesis Design , Risk Factors , Transcatheter Aortic Valve Replacement/methods , Transcatheter Aortic Valve Replacement/mortality , Treatment OutcomeABSTRACT
BACKGROUND: Transcatheter aortic valve replacement (TAVR) using a self-expanding valve has been shown to be superior to an open operation in high-risk patients. Extensive iliofemoral peripheral vascular disease can prohibit femoral access. In these cases, direct aortic (DA) implantation may be a suitable option. METHODS: The current analysis compared outcomes in patients undergoing TAVR with the self-expanding CoreValve prosthesis (Medtronic, Minneapolis, MN) by direct aortic (DA) access vs iliofemoral (IF) access. Patients treated in the CoreValve US High Risk and Extreme Risk Pivotal Trials and Continued Access Study were included. Propensity score matching was used to account for differences in baseline characteristics between groups. Clinical outcomes were compared at 30 days and 1 year. RESULTS: We identified 394 matched pairs of IF and DA patients. The all-cause mortality rate was significantly higher in the DA group than in the IF group at 30 days (10.9% vs 4.1%, p < 0.001), but this difference was reduced at 1 year (28.1% vs 23.2%, p = 0.063). All-cause mortality or major stroke was significantly higher for DA vs IF access at 30 days (13.5% vs 5.3%, p < 0.001) and at 1 year (30.4% vs 24.2%, p = 0.025). Major/life-threatening bleeding and acute kidney injury were significantly greater in the DA group at 30 days (66.7% vs 35.4% and 19.7% vs 10.0%, respectively, both p < 0.001). CONCLUSIONS: When femoral access is not feasible, DA access allows effective delivery of the valve but incurs an increased risk of death and adverse events, potentially the result of procedural differences.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Heart Valve Prosthesis , Propensity Score , Transcatheter Aortic Valve Replacement/methods , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve Stenosis/diagnosis , Echocardiography , Female , Humans , Male , Prosthesis Design , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: While transcatheter aortic valve implantation (TAVI) has traditionally been supported intraprocedurally by transoesophageal echocardiography (TOE), transthoracic echocardiography (TTE) is increasingly being used. We evaluated echocardiographic imaging characteristics and clinical outcomes in patients who underwent TTE during TAVI (TTE-TAVI). METHODS AND RESULTS: A select team of dedicated sonographers and interventional echocardiographers performed TTE-TAVI in 278 patients, all of whom underwent TAVI through transfemoral access. We implanted the Medtronic EVOLUT R valve in 258 patients (92.8%). TTE images were acquired immediately pre-procedure by a dedicated sonographer in the cardiac catheterization laboratory with the patient in the supine position. TTE was then performed post deployment of TAVI. In the procedure, TTE image quality was fair or better in 249 (89.6%) cases. Color-flow Doppler was adequate or better in 275 (98.9%) cases. In 2 cases, paravalvular regurgitation (PVL) could not be assessed confidently by echocardiography due to poor image quality; in those cases, PVL was assessed by fluoroscopy, aortic root injection and invasive hemodynamics. Both TTE and invasive hemodynamics were used in the assessment of need for post-deployment stent ballooning (n = 23, 8.3%). TTE adequately recognized new pericardial effusion in 3 cases. No case required TOE conversion for image quality. There was only 1 case of intraprocedural TTE failing to recognize moderate PVL, without clinical implication. In 99% of patients, TTE-TAVI adequately assessed PVL compared with 24-h and 1-month follow-up TTE. CONCLUSIONS: With the current generation of TAVI, TTE-TAVI is adequate intraprocedurally when performed by specialized sonographers and dedicated cardiologists in a highly experienced TAVI center.
ABSTRACT
OBJECTIVES: This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). BACKGROUND: Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. METHODS: The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. RESULTS: SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). CONCLUSIONS: Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.
Subject(s)
Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Prosthesis Failure , Transcatheter Aortic Valve Replacement/instrumentation , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/mortality , Aortic Valve Insufficiency/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Echocardiography , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Hemodynamics , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Prospective Studies , Quality of Life , Recovery of Function , Recurrence , Reoperation , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment OutcomeABSTRACT
BACKGROUND: End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined. METHODS: The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year. RESULTS: Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm2, mean gradient 9.33 mm Hg) CONCLUSIONS: Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year.
Subject(s)
Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/surgery , Kidney Failure, Chronic/complications , Postoperative Complications/mortality , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Cause of Death , Comorbidity , Echocardiography , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Kidney Failure, Chronic/diagnostic imaging , Male , Postoperative Complications/diagnostic imaging , Prospective Studies , Renal Replacement Therapy , Risk Factors , Survival RateABSTRACT
OBJECTIVES: This study aimed to compare the association of access site complications and the use of unfractionated heparin versus bivalirudin during subinguinal peripheral vascular intervention. BACKGROUND: Compared to unfractionated heparin, bivalirudin has been associated with fewer bleeding complications in patients undergoing percutaneous coronary intervention but more ischemic events. The safety and efficacy of direct thrombin inhibitors in peripheral vascular interventions is not well defined. METHODS: We compared the incidence of in-hospital access site complications and discharge status among patients in the multicenter, prospective Vascular Quality Initiative registry who underwent peripheral vascular intervention between August 2007 and January 2014 using bivalirudin or unfractionated heparin. Propensity score matching was used to obtain a balanced cohort of 1,524 patients in each treatment group. RESULTS: Patients treated with bivalirudin had a significantly lower incidence of access site hematomas (2.4% vs. 3.9%, P = 0.018), shorter post-procedural hospitalization (1.0 vs. 1.2 days, P < 0.001) and lower rates of discharge to a nursing home or rehabilitation center rather than home (7.61% vs. 9.73%, P = 0.034) when compared with unfractionated heparin-treated patients. The incidence of in-hospital access site occlusion, distal embolization, and mortality did not differ significantly between groups. CONCLUSIONS: Patients who received bivalirudin had lower rates of access site hematoma, shorter length of stay, and improved discharge status compared with unfractionated heparin during hospitalization for peripheral vascular intervention. Randomized comparisons of these agents are needed to confirm these findings. © 2016 Wiley Periodicals, Inc.
Subject(s)
Anticoagulants/administration & dosage , Antithrombins/administration & dosage , Catheterization, Peripheral , Heparin/administration & dosage , Hirudins/administration & dosage , Peptide Fragments/administration & dosage , Aged , Anticoagulants/adverse effects , Antithrombins/adverse effects , Canada , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/mortality , Chi-Square Distribution , Female , Hematoma/chemically induced , Hemorrhage/chemically induced , Heparin/adverse effects , Hirudins/adverse effects , Humans , Length of Stay , Logistic Models , Male , Odds Ratio , Patient Discharge , Peptide Fragments/adverse effects , Propensity Score , Punctures , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Registries , Retrospective Studies , Risk Factors , Treatment Outcome , United StatesABSTRACT
Surgical treatment of mitral stenosis with extreme calcification remains a challenge. Recently, the balloon-expandable valve prosthesis, anchored by radial force, offers a new option for these patients. We present 2 cases of transcatheter mitral valve replacement in patients with severe native mitral valve stenosis and annular calcification deemed too extensive for conventional surgical techniques.
Subject(s)
Cardiac Catheterization/methods , Heart Valve Prosthesis Implantation/methods , Mitral Valve Stenosis/surgery , Aged , Echocardiography, Three-Dimensional , Echocardiography, Transesophageal , Female , Humans , Mitral Valve Stenosis/diagnostic imaging , Prosthesis DesignABSTRACT
STUDY OBJECTIVES: To estimate periprocedural bleeding risk before elective percutaneous coronary intervention (PCI) by using a point-of-care bleeding risk calculator and to document changes in anticoagulant use and bleeding complications after implementation of use of this calculator. DESIGN: Prospective observational pilot study with a historical control cohort. SETTING: Tertiary care medical center. PATIENTS: The pilot cohort consisted of 100 patients undergoing ad hoc PCI during elective cardiac catheterization procedures between January and May 2013, whose bleeding risk and accompanying PCI anticoagulant recommendations were determined by the use of a pre-PCI point-of-care bleeding risk calculator. The historical control cohort consisted of all patients who underwent elective PCI at the same facility between April 1, 2011, and March 31, 2012, before implementation of use of the bleeding risk calculator. MEASUREMENTS AND MAIN RESULTS: The pre-PCI bleeding risk calculator distinguished patients in the pilot cohort as high risk (score 12 or higher) or low risk (lower than 12) for bleeding after a PCI procedure. The primary outcome was bivalirudin use in the pilot cohort compared with its use in the historical control cohort. Implementation of the bleeding risk calculator significantly decreased bivalirudin use compared with bivalirudin use in the historical control cohort (87% in the control cohort vs 60% in the pilot cohort, p<0.01). Bivalirudin use remained high in patients at high bleeding risk (82.2% in the pilot cohort vs 87.4% in the control cohort, p=0.3) and its use was decreased in patients at low bleeding risk (41.8% in the pilot cohort vs 87.1% in the control cohort, p<0.01). The incidence of bleeding complications in the pilot cohort was comparable with that in the control cohort (1% vs. 0.4%, p=0.37), although this pilot study was underpowered to potentially detect a significant change in the incidence of bleeding complications. CONCLUSION: A simple bleeding risk calculator can substantially reduce overall bivalirudin use by specifically decreasing its use among patients at low bleeding risk while maintaining its use among patients at high bleeding risk. The incidence of bleeding complications remained unchanged despite decreasing bivalirudin use among patients undergoing elective coronary catheterization who were at low risk for bleeding.
Subject(s)
Anticoagulants/therapeutic use , Hemorrhage/prevention & control , Percutaneous Coronary Intervention/adverse effects , Point-of-Care Systems , Aged , Aged, 80 and over , Female , Glomerular Filtration Rate , Health Care Costs , Hemorrhage/economics , Hirudins , Humans , Male , Peptide Fragments/therapeutic use , Pilot Projects , Prospective Studies , Recombinant Proteins/therapeutic use , Risk AssessmentABSTRACT
BACKGROUND: Access site hematomas and pseudoaneurysms are the most frequent complications of peripheral vascular intervention (PVI); however, their incidence and risk factors remain unclear. METHODS AND RESULTS: We retrospectively analyzed data from the multicenter Vascular Quality Initiative on 22 226 patients who underwent 27 048 PVI from August 2007 to May 2013. Primary end points included incidence and predictors of access site complications (ASCs), length of postprocedural hospitalization, discharge status, and 30-day and 1-year mortality. ASC complicated 936 procedures (3.5%). Of these, 74.4% were minor complications, 9.7% were moderate requiring transfusion, 5.4% were moderate requiring thrombin injection, and 10.5% were severe requiring surgery. Predictors of ASC were age >75 years, female sex, white race, no prior PVI, nonfemoral arterial access site, >6-Fr sheath size, thrombolytics, arterial dissection, fluoroscopy time >30 minutes, nonuse of vascular closure device, bedridden preoperative ambulatory status, and urgent indication. Mean hospitalization was longer after procedures complicated by ASC (1.2±1.6 versus 1.9±1.9 days; range, 0-7 days; P=0.002). Severity of ASC correlated with higher rates of discharge to rehabilitation/nursing facilities compared with home discharge. Patients with severe ASC had higher 30-day mortality (6.1% versus 1.4%; P<0.001), and those with moderate ASC requiring transfusion had elevated 1-year mortality (12.1% versus 5.7%; P<0.001). CONCLUSIONS: Several factors independently predict ASC after PVI. Appropriate use of antithrombotic therapies and vascular closure device in patients at increased risk of ASC may improve post-PVI outcomes.
Subject(s)
Aneurysm, False/epidemiology , Catheterization, Peripheral/adverse effects , Hematoma/epidemiology , Aged , Aneurysm, False/diagnosis , Aneurysm, False/mortality , Aneurysm, False/prevention & control , Aneurysm, False/therapy , Anticoagulants/therapeutic use , Blood Transfusion , Catheterization, Peripheral/instrumentation , Catheterization, Peripheral/mortality , Female , Fibrinolytic Agents/therapeutic use , Hematoma/diagnosis , Hematoma/mortality , Hematoma/prevention & control , Hematoma/therapy , Humans , Incidence , Length of Stay , Male , Middle Aged , Retrospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
PURPOSE: To evaluate the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoropopliteal artery (FPA) and to identify factors associated with loss of patency. MATERIALS AND METHODS: In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age, 67 y), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56% of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio< 2.5. RESULTS: At 12 months, Rutherford category and ankle-brachial index (ABI) were significantly improved (mean category improvement, 2.4; ABI increased from 0.6±0.2 to 0.9±0.19; P<.0001). Primary and secondary patency rates were 73% and 92%. The primary patency for devices oversized<20% at the proximal landing zone was 88%, whereas the primary patency for devices oversized by>20% was 70% (P = .047). Primary patency was not significantly affected by device diameter (5 vs 6 vs 7 mm) or lesion length (≤20 cm vs>20 cm). The 30-day major adverse event rate was 0.8%. CONCLUSIONS: The heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73% at 1 year in the treatment of long-segment FPA disease. Careful sizing of the device relative to vessel landing zones is essential for achieving optimal outcomes.
Subject(s)
Drug-Eluting Stents , Heparin/administration & dosage , Peripheral Arterial Disease/therapy , Polytetrafluoroethylene/chemistry , Aged , Anticoagulants/administration & dosage , Coated Materials, Biocompatible/chemical synthesis , Equipment Design , Equipment Failure Analysis , Female , Femoral Artery/drug effects , Femoral Artery/surgery , Humans , Male , Peripheral Arterial Disease/diagnosis , Popliteal Artery/drug effects , Popliteal Artery/surgery , Treatment Outcome , United StatesABSTRACT
BACKGROUND: We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results. METHODS: The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years). RESULTS: At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral. CONCLUSIONS: In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270 [ClinicalTrials.gov].).
Subject(s)
Carotid Stenosis/therapy , Endarterectomy, Carotid , Stents , Stroke/prevention & control , Adult , Angioplasty, Balloon , Carotid Stenosis/mortality , Carotid Stenosis/surgery , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Myocardial Infarction/epidemiology , Myocardial Infarction/prevention & control , Risk Factors , Stroke/epidemiologyABSTRACT
BACKGROUND: Carotid endarterectomy is more effective than medical management in the prevention of stroke in patients with severe symptomatic or asymptomatic atherosclerotic carotid-artery stenosis. Stenting with the use of an emboli-protection device is a less invasive revascularization strategy than endarterectomy in carotid-artery disease. METHODS: We conducted a randomized trial comparing carotid-artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent. The primary end point of the study was the cumulative incidence of a major cardiovascular event at 1 year--a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy. RESULTS: The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting with an emboli-protection device (cumulative incidence, 12.2 percent) and in 32 patients randomly assigned to undergo endarterectomy (cumulative incidence, 20.1 percent; absolute difference, -7.9 percentage points; 95 percent confidence interval, -16.4 to 0.7 percentage points; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, carotid revascularization was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04). CONCLUSIONS: Among patients with severe carotid-artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy.
Subject(s)
Carotid Stenosis/therapy , Endarterectomy, Carotid , Stents , Adult , Aged , Aged, 80 and over , Angioplasty, Balloon/instrumentation , Carotid Stenosis/mortality , Carotid Stenosis/surgery , Comorbidity , Disease-Free Survival , Embolism/prevention & control , Embolism/therapy , Equipment Design , Humans , Incidence , Middle Aged , Myocardial Infarction/prevention & control , Risk Factors , Stroke/prevention & controlABSTRACT
BACKGROUND: Patent Foramen Ovale (PFO) occurs in approximately 25% of the population and has been implicated in the etiology of cryptogenic stroke. Although the exact mechanism of PFO's role in stroke has not been defined, there is a growing body of evidence that supports both the safety and therapeutic benefit of PFO closure in cryptogenic stroke. Current methods of therapy include anticoagulation, surgical closure, and percutaneous closure. METHODS: We completed a retrospective analysis of data from the first 20 PFO closures at our institution and evaluated the current literature on PFO treatment. RESULTS: Percutaneous closure had a 100% technical success rate. There were no procedural complications and only 1 episode of supraventricular arrhythmia requiring therapy. CONCLUSION: Percutaneous closure is associated with a high technical success rate, decreased morbidity compared to surgery, and equal benefits after endothelialization of the device. As the mechanisms involved in PFO are better delineated, clear guidelines can be established for the percutaneous closure and follow-up of PFO.