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Patient radiation exposure during transcatheter aortic valve replacement procedures

Daneault, Benoit; Balter, Stephen; Kodali, Susheel K; Williams, Mathew R; Genereux, Philippe; Reiss, George R; Paradis, Jean-Michel; Green, Philip; Kirtane, Ajay J; Smith, Craig; Moses, Jeffrey W; Leon, Martin B
AIMS: To describe patient radiation utilisation during transcatheter aortic valve replacement (TAVR) on a series of consecutive patients. METHODS AND RESULTS: Data on radiation exposure were prospectively collected for consecutive patients undergoing TAVR and percutaneous coronary interventions at our centre. Radiation dose during the procedure was recorded using the US Food and Drug Administration (FDA) reference point (Ka,r) and the dose area product (PKA). In addition to quantifying overall radiation doses during TAVR, radiation exposure during transfemoral (TF) (n=79) and transapical (TA) (n=26) cases was compared. The median radiation dose during TAVR was 1,639 mGy (983-2,420), or 188 (106-321) Gy*cm2. Radiation dose was significantly lower among TA patients using either the reference point (TA: 946 [777-1,261] vs. TF: 1,932 [1,383-2,614] mGy; p<0.001) or the dose area product (TA: 89 [60-115] vs. TF: 236 [164-338] Gy*cm2; p<0.001). Fluoroscopy time was lower for TA patients (TA: 10 [8-11] vs. TF: 30 [24-34] minutes; p<0.001). Operators experience did not affect radiation exposure for TF cases. CONCLUSIONS: Radiation exposure during TAVR appears similar to other percutaneous coronary interventions of moderate complexity. Radiation doses were significantly lower for TA procedures. A higher dose of radiation in TF patients may be related to additional imaging requirements to optimise percutaneous vascular access and closure.
PMCID:3718041
PMID: 23086785
ISSN: 1774-024x
CID: 750192

The impact of frailty status on survival after transcatheter aortic valve replacement in older adults with severe aortic stenosis: a single-center experience

Green, Philip; Woglom, Abigail E; Genereux, Philippe; Daneault, Benoit; Paradis, Jean-Michel; Schnell, Susan; Hawkey, Marian; Maurer, Mathew S; Kirtane, Ajay J; Kodali, Susheel; Moses, Jeffrey W; Leon, Martin B; Smith, Craig R; Williams, Mathew
OBJECTIVES: This study sought to evaluate the impact of frailty in older adults undergoing transcatheter aortic valve replacement (TAVR) for symptomatic aortic stenosis. BACKGROUND: Frailty status impacts prognosis in older adults with heart disease; however, the impact of frailty on prognosis after TAVR is unknown. METHODS: Gait speed, grip strength, serum albumin, and activities of daily living status were collected at baseline and used to derive a frailty score among patients who underwent TAVR procedures at a single large-volume institution. The cohort was dichotomized on the basis of median frailty score into frail and not frail groups. The impact of frailty on procedural outcomes (stroke, bleeding, vascular complications, acute kidney injury, and mortality at 30 days) and 1-year mortality was evaluated. RESULTS: Frailty status was assessed in 159 subjects who underwent TAVR (age 86 +/- 8 years, Society of Thoracic Surgery Risk Score 12 +/- 4). Baseline frailty score was not associated with conventionally ascertained clinical variables or Society of Thoracic Surgery score. Although high frailty score was associated with a longer post-TAVR hospital stay when compared with lower frailty score (9 +/- 6 days vs. 6 +/- 5 days, respectively, p = 0.004), there were no significant crude associations between frailty status and procedural outcomes, suggesting adequacy of the standard selection process for identifying patients at risk for periprocedural complications after TAVR. Frailty status was independently associated with increased 1-year mortality (hazard ratio: 3.5, 95% confidence interval: 1.4 to 8.5, p = 0.007) after TAVR. CONCLUSIONS: Frailty was not associated with increased periprocedural complications in patients selected as candidates to undergo TAVR but was associated with increased 1-year mortality after TAVR. Further studies will evaluate the independent value of this frailty composite in older adults with aortic stenosis.
PMCID:3717525
PMID: 22995885
ISSN: 1876-7605
CID: 750212

Transcatheter aortic-valve replacement for inoperable severe aortic stenosis

Makkar, Raj R; Fontana, Gregory P; Jilaihawi, Hasan; Kapadia, Samir; Pichard, Augusto D; Douglas, Pamela S; Thourani, Vinod H; Babaliaros, Vasilis C; Webb, John G; Herrmann, Howard C; Bavaria, Joseph E; Kodali, Susheel; Brown, David L; Bowers, Bruce; Dewey, Todd M; Svensson, Lars G; Tuzcu, Murat; Moses, Jeffrey W; Williams, Matthew R; Siegel, Robert J; Akin, Jodi J; Anderson, William N; Pocock, Stuart; Smith, Craig R; Leon, Martin B
BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known. METHODS: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed. RESULTS: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation. CONCLUSIONS: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
PMID: 22443478
ISSN: 0028-4793
CID: 750252

Gait speed and dependence in activities of daily living in older adults with severe aortic stenosis

Green, Philip; Woglom, Abigail E; Genereux, Philippe; Maurer, Mathew S; Kirtane, Ajay J; Hawkey, Marian; Schnell, Susan; Sohn, Jeanie; Moses, Jeffrey W; Leon, Martin B; Smith, Craig R; Williams, Mathew; Kodali, Susheel
BACKGROUND: In the transcatheter aortic valve replacement era, characterization of functional status in older adults with aortic stenosis (AS) is essential. Gait speed (GS) is emerging as a marker of frailty and predictor of outcomes in older adults undergoing cardiovascular intervention. The objective of this study was to delineate the prevalence of slow GS, evaluate the association of GS with factors used in standard cardiovascular assessments, and evaluate the association of GS with dependence in activities of daily living (ADLs) in older adults with AS. HYPOTHESIS: We hypothesized that gait speed would not be associated with clinical factors, but would be associated with ADLs. METHODS: We evaluated GS, ADLs dependence, and Society of Thoracic Surgery score along with clinical and functional assessments in 102 older adults with AS being evaluated for transcatheter valve. Gait speed <0.5 m/s was considered slow, and GS >/=0.5 m/s was considered preserved. We assessed the association of covariates with GS as well as with ADLs dependence. RESULTS: Median GS was 0.37 m/s (interquartile range, 0.0-0.65 m/s). Sixty-four (63%) subjects had slow GS. Of commonly employed clinical covariates, only prior coronary intervention and serum albumin were weakly associated with GS. However, GS was independently associated with ADLs dependence (Odds ratio: 1.52 [1.21-1.91] for every 0.1 m/s decrease in GS; P = 0.0003). CONCLUSIONS: Although the prevalence of slow GS in a population of elderly patients with severe AS being screened for transcatheter valve was high, there were only weak associations between GS and other risk stratifying tools. The strong association between GS and dependent functional status suggests that assessment of gait speed is a useful, objectively measurable, risk stratification tool in this population.
PMCID:3702449
PMID: 22331630
ISSN: 0160-9289
CID: 750262

ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 appropriate use criteria for diagnostic catheterization: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society of Critical Care Medicine, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, Society of Thoracic Surgeons

Patel, Manesh R; Bailey, Steven R; Bonow, Robert O; Chambers, Charles E; Chan, Paul S; Dehmer, Gregory J; Kirtane, Ajay J; Samuel Wann, L; Parker Ward, R; Douglas, Pamela S; Patel, Manesh R; Bailey, Steven R; Altus, Philip; Barnard, Denise D; Blankenship, James C; Casey, Donald E Jr; Dean, Larry S; Fazel, Reza; Gilchrist, Ian C; Kavinsky, Clifford J; Lakoski, Susan G; Le, D Elizabeth; Lesser, John R; Levine, Glenn N; Mehran, Roxana; Russo, Andrea M; Sorrentino, Matthew J; Williams, Mathew R; Wong, John B; Wolk, Michael J; Bailey, Steven R; Douglas, Pamela S; Hendel, Robert C; Kramer, Christopher M; Min, James K; Patel, Manesh R; Shaw, Leslee; Stainback, Raymond F; Allen, Joseph M
PMID: 22710040
ISSN: 0022-5223
CID: 199702

ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 appropriate use criteria for diagnostic catheterization: American College of Cardiology Foundation Appropriate Use Criteria Task Force Society for Cardiovascular Angiography and Interventions American Association for Thoracic Surgery American Heart Association, American Society of Echocardiography American Society of Nuclear Cardiology Heart Failure Society of America Heart Rhythm Society, Society of Critical Care Medicine Society of Cardiovascular Computed Tomography Society for Cardiovascular Magnetic Resonance Society of Thoracic Surgeons

Patel, Manesh R; Bailey, Steven R; Bonow, Robert O; Chambers, Charles E; Chan, Paul S; Dehmer, Gregory J; Kirtane, Ajay J; Wann, L Samuel; Ward, R Parker; Douglas, Pamela S; Patel, Manesh R; Bailey, Steven R; Altus, Philip; Barnard, Denise D; Blankenship, James C; Casey, Donald E Jr; Dean, Larry S; Fazel, Reza; Gilchrist, Ian C; Kavinsky, Clifford J; Lakoski, Susan G; Le, D Elizabeth; Lesser, John R; Levine, Glenn N; Mehran, Roxana; Russo, Andrea M; Sorrentino, Matthew J; Williams, Mathew R; Wong, John B; Wolk, Michael J; Bailey, Steven R; Douglas, Pamela S; Hendel, Robert C; Kramer, Christopher M; Min, James K; Patel, Manesh R; Shaw, Leslee; Stainback, Raymond F; Allen, Joseph M
The American College of Cardiology Foundation, in collaboration with the Society for Cardiovascular Angiography and Interventions and key specialty and subspecialty societies, conducted a review of common clinical scenarios where diagnostic catheterization is frequently considered. The indications (clinical scenarios) were derived from common applications or anticipated uses, as well as from current clinical practice guidelines and results of studies examining the implementation of noninvasive imaging appropriate use criteria. The 166 indications in this document were developed by a diverse writing group and scored by a separate independent technical panel on a scale of 1 to 9, to designate appropriate use (median 7 to 9), uncertain use (median 4 to 6), and inappropriate use (median 1 to 3). Diagnostic catheterization may include several different procedure components. The indications developed focused primarily on 2 aspects of diagnostic catheterization. Many indications focused on the performance of coronary angiography for the detection of coronary artery disease with other procedure components (e.g., hemodynamic measurements, ventriculography) at the discretion of the operator. The majority of the remaining indications focused on hemodynamic measurements to evaluate valvular heart disease, pulmonary hypertension, cardiomyopathy, and other conditions, with the use of coronary angiography at the discretion of the operator. Seventy-five indications were rated as appropriate, 49 were rated as uncertain, and 42 were rated as inappropriate. The appropriate use criteria for diagnostic catheterization have the potential to impact physician decision making, healthcare delivery, and reimbursement policy. Furthermore, recognition of uncertain clinical scenarios facilitates identification of areas that would benefit from future research. (c) 2012 Wiley Periodicals, Inc.
PMID: 22678595
ISSN: 1522-1946
CID: 199712

Two-year outcomes after transcatheter or surgical aortic-valve replacement

Kodali, Susheel K; Williams, Mathew R; Smith, Craig R; Svensson, Lars G; Webb, John G; Makkar, Raj R; Fontana, Gregory P; Dewey, Todd M; Thourani, Vinod H; Pichard, Augusto D; Fischbein, Michael; Szeto, Wilson Y; Lim, Scott; Greason, Kevin L; Teirstein, Paul S; Malaisrie, S Chris; Douglas, Pamela S; Hahn, Rebecca T; Whisenant, Brian; Zajarias, Alan; Wang, Duolao; Akin, Jodi J; Anderson, William N; Leon, Martin B
BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
PMID: 22443479
ISSN: 0028-4793
CID: 166971

Periaortic hematoma after transcatheter aortic valve replacement: Description of a new complication

Genereux P; Reiss GR; Kodali SK; Williams MR; Hahn RT
We report a case series of three patients with periaortic hematomas following transcatheter aortic valve replacement (TAVR). The TAVRs were performed by either trans-apical or transfemoral approach. An intraprocedural transesophageal echocardiogram (TEE) was performed in all patients. Clinical features of all three cases included advanced age, female gender, and small body weight. In addition, the following characteristics were present in all cases: presence of bulky calcification of the noncoronary cusp (NCC) of the aortic valve, mismatch between the annulus and device diameter, and severe intraprocedural hypertension immediately following TAVR. These characteristics may be potential causative factors. Early recognition of this complication by intra-procedural TEE was integral to the initiation of rapid and appropriate therapy, resulting in a favorable outcome. Herein, we present possible theories for the occurrence of this rare complication. (c) 2011 Wiley Periodicals, Inc
PMID: 21805578
ISSN: 1522-726x
CID: 150622

On-pump versus off-pump surgical revascularization in patients with acute coronary syndromes: analysis from the Acute Catheterization and Urgent Intervention Triage Strategy trial

Ben-Gal, Yanai; Stone, Gregg W; Smith, Craig R; Williams, Mathew R; Weisz, Giora; Stewart, Allan S; Takayama, Hiroo; Genereux, Philippe; Argenziano, Michael
OBJECTIVE: Early invasive strategy, defined as early coronary angiography and subsequent revascularization, when appropriate, is recommended by current guidelines for the management of patients with moderate- to high-risk acute coronary syndromes. We sought to compare the outcomes of patients with acute coronary syndromes undergoing surgical revascularization with an on-pump versus off-pump approach. METHODS: Among a total of 13,819 patients with moderate- to high-risk acute coronary syndromes enrolled in the Acute Catheterization and Urgent Intervention Triage Strategy trial, 1375 patients were triaged to isolated coronary artery bypass grafting. One thousand one hundred fifty-four patients underwent operations with cardiopulmonary bypass (the coronary artery bypass grafting group), and 221 patients underwent off-pump coronary artery bypass grafting (the off-pump coronary artery bypass grafting group). Propensity score matching (1:3) was applied to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 880 matched patients with acute coronary syndromes (220 managed with off-pump coronary artery bypass grafting and 660 managed with coronary artery bypass grafting). RESULTS: At 30 days, patients undergoing off-pump coronary artery bypass grafting had fewer events of bleeding (43.7% vs 56.3%, P = .0005) and myocardial infarction (7.3% vs 12.1%, P = .055) but higher rates of reintervention (3.7% vs 1.2%, P = .02). At 1 year, there was no difference between groups in death, total myocardial infarctions, reinterventions, strokes, or major adverse cardiac events, but there was a lower rate of non-Q-wave myocardial infarctions in the off-pump coronary artery bypass grafting group (4.6% vs 9.2%, P = .03). CONCLUSIONS: In this large-scale study evaluating the outcomes of patients with acute coronary syndromes, off-pump coronary artery bypass grafting was associated with lower rates of bleeding and non-Q-wave myocardial infarction but more reinterventions early after the procedure. At 1 year, there was no major outcome difference between the 2 surgical strategies.
PMID: 21529848
ISSN: 0022-5223
CID: 1067112

Aortic root and right ventricular outflow tract reconstruction using composite biological valved conduits after failed Ross procedure [Case Report]

Russo, Mark J; Easterwood, Rachel; Williams, Mathew R; George, Isaac; Stewart, Allan S
The Ross procedure or pulmonary autograft has been frequently used for surgical treatment of aortic valve disease. One considerable disadvantage of the Ross procedure is the involvement of two valves (aortic and pulmonary) in treatment of single (aortic) valve disease. Both the aortic and pulmonary valves are at risk for future degeneration. Concurrent failure of both valves after a Ross procedure is rare but presents a significant technical challenge when reoperation is necessary. We describe a novel approach to this complication using composite biological valved conduits comprised of stentless bioprosthetic valves and polyester grafts.
PMID: 21619955
ISSN: 0003-4975
CID: 1067122