Brian K. Whisenant

The presence and identification of organisms transmitted to dental laboratories

The potential for infection of dental personnel in the office and dental laboratory by transmission of microorganisms between dentists offices and commercial dental laboratories does exist. Sixty-seven percent of all materials sent from dental offices to dental laboratories sampled in four cities were contaminated with bacteria of varying degrees of opportunistic pathogenicity. Dental offices and dental laboratories need to practice adequate infection control procedures to prevent possible cross-contamination.

Elective coronary angiography and percutaneous coronary intervention during uninterrupted warfarin therapy

The management of patients anticoagulated with warfarin and referred for coronary angiography presents a substantial challenge to the physician who must minimize risks of periprocedural hemorrhage and thromboembolism. The aim of this study was to evaluate the feasibility and safety of performing diagnostic coronary angiography and percutaneous coronary intervention during uninterrupted warfarin therapy. Patients treated with warfarin were prospectively identified and enrolled in the study. Nineteen diagnostic cardiac catheterizations and six percutaneous coronary interventions were performed in 23 patients. The mean international normalized ratio was 2.4 ± 0.5 (range, 1.8–3.5). Hemostasis was achieved with AngioSeal following 21 procedures and with Perclose following 4 procedures. No patient experienced a predefined endpoint. Specifically, no patient experienced procedure‐related myocardial infarction, major or minor bleeding. We conclude that cardiac catheterization and percutaneous coronary intervention may be considered in the setting of uninterrupted warfarin therapy. Catheter Cardiovasc Interv 2003;60:180–184.

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation

BACKGROUNDnLimited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR).nnnOBJECTIVESnThis study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR.nnnMETHODSnFrom the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices.nnnRESULTSnA total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; pxa0=xa00.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; pxa0< 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; pxa0< 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; pxa0=xa00.007) and post-procedural ARxa0≥ moderate (4.2% vs. 18.8%; pxa0< 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural ARxa0≥ moderate compared with those with post-procedural ARxa0≤xa0mild (46.1% vs. 21.8%; log-rank pxa0=xa00.001). On multivariable analysis, post-procedural ARxa0≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; pxa0=xa00.001).nnnCONCLUSIONSnCompared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.

Procedural and Clinical Outcomes in Transcatheter Aortic Valve Replacement for Bicuspid Versus Tricuspid Aortic Valve Stenosis

BACKGROUNDnTranscatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS).nnnOBJECTIVESnThis study sought to compare the procedural and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry.nnnMETHODSnOutcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria.nnnRESULTSnCompared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; pxa0= 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; pxa0= 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; pxa0= 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; pxa0= 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; pxa0= 0.28).nnnCONCLUSIONSnCompared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereasxa0noxa0differences were observed with the new-generation devices.

Repeated measurement of the intermountain risk score enhances prognostication for mortality.

Background The Intermountain Risk Score (IMRS), composed of the complete blood count (CBC) and basic metabolic profile (BMP), predicts mortality and morbidity in medical and general populations. Whether longitudinal repeated measurement of IMRS is useful for prognostication is an important question for its clinical applicability. Methods Females (Nu200a=u200a5,698) and males (Nu200a=u200a5,437) with CBC and BMP panels measured 6 months to 2.0 years apart (mean 1.0 year) had baseline and follow-up IMRS computed. Survival analysis during 4.0±2.5 years (maximum 10 years) evaluated mortality (females: nu200a=u200a1,255 deaths; males: nu200a=u200a1,164 deaths) and incident major events (myocardial infarction, heart failure [HF], and stroke). Results Both baseline and follow-up IMRS (categorized as high-risk vs. low-risk) were independently associated with mortality (all p<0.001) in bivariable models. For females, follow-up IMRS had hazard ratio (HR)u200a=u200a5.23 (95% confidence interval [CI]u200a=u200a4.11, 6.64) and baseline IMRS had HRu200a=u200a3.66 (CIu200a=u200a2.94, 4.55). Among males, follow-up IMRS had HRu200a=u200a4.28 (CIu200a=u200a3.51, 5.22) and baseline IMRS had HRu200a=u200a2.32 (CIu200a=u200a1.91, 2.82). IMRS components such as RDW, measured at both time points, also predicted mortality. Baseline and follow-up IMRS strongly predicted incident HF in both genders. Conclusions Repeated measurement of IMRS at baseline and at about one year of follow-up were independently prognostic for mortality and incident HF among initially hospitalized patients. RDW and other CBC and BMP values were also predictive of outcomes. Further research should evaluate the utility of IMRS as a tool for clinical risk adjustment.

The intermountain risk score predicts incremental age-specific long-term survival and life expectancy

The Intermountain Risk Score (IMRS) encapsulates the mortality risk information from all components of the complete blood count (CBC) and basic metabolic profile (BMP), along with age. To individualize the IMRS more clearly, this study evaluated whether IMRS weightings for 1-year mortality predict age-specific survival over more than a decade of follow-up. Sex-specific 1-year IMRS values were calculated for general medical patients with CBC and BMP laboratory tests drawn during 1999-2005. The population was divided randomly 60% (N = 71,921, examination sample) and 40% (N = 47,458, validation sample). Age-specific risk thresholds were established, and both survival and life expectancy were compared across low-, moderate-, and high-risk IMRS categories. During 7.3 ± 1.8 years of follow-up (range, 4.5-11.1 years), the average IMRS of decedents was higher than censored in all age/sex strata (all P < 0.001). For examination and validation samples, every age stratum had incrementally lower survival for higher risk IMRS, with hazard ratios of 2.5-8.5 (P < 0.001). Life expectancies were also significantly shorter for higher risk IMRS (all P < 0.001): For example, among 50-59 year-olds, life expectancy was 7.5, 6.8, and 5.9 years for women with low-, moderate-, and high-risk IMRS (with mortality in 5.7%, 16.3%, and 37.0% of patients, respectively). In Men, life expectancy was 7.3, 6.8, and 5.4 for low-, moderate-, and high-risk IMRS (with patients having 7.3%, 19.5%, and 40.0% mortality), respectively. IMRS significantly stratified survival and life expectancy within age-defined subgroups during more than a decade of follow-up. IMRS may be used to stratify age-specific risk of mortality in research, clinical/preventive, and quality improvement applications. A web calculator is located at http://intermountainhealthcare.org/IMRS.

Left Atrial Appendage Occlusion Addresses the Tremendous Unmet Needs of Stroke Prevention in Atrial Fibrillation That Persist Despite Recent Advances in Anticoagulation Therapy

Oral anticoagulation is the standard of care for stroke prevention in atrial fibrillation but falls short of providing an adequate solution to this common threat when considered from both efficacy and safety perspectives. Anticoagulation-associated treatment deficits include major and minor bleeding, refusal of anticoagulation based on anticoagulation risk, lack of medication adherence, personal and physician preference, and a persistent risk of ischemic stroke and major adverse cardiovascular events despite use. The challenges of contemporary anticoagulation management are highlighted in a recent large national assessment of warfarin therapy use involving 138 319 patients and 2 683 674 international normalized ratio results with reported mean time in therapeutic range of only 53.7%.1 Even in the setting of optimal management without clinically relevant major bleeds, emerging data regarding long-term risk of cerebral microbleeds prompt the need to explore risk and benefits of long-term anticoagulation use in patients with atrial fibrillation.2,3nnResponse by Ezekowitz and Kent on p 1524nnAmong atrial fibrillation patients who experience a stroke, the large majority are felt to originate from left atrial appendage (LAA) thromboembolism.4,5 Accordingly, despite the lack of randomized data, LAA ligation is a frequent adjunct to cardiac surgery in patients with atrial fibrillation. Minimally invasive transcatheter occlusion systems are now available and minimize the invasive nature of open and thorascopic surgical approaches. The long-term outcomes from multiple trials using the Watchman LAA occlusion system (Boston Scientific, Natick, MA) have demonstrated that endocardial left atrial appendage closure provides similar protection against stroke, systemic embolism, and cardiovascular mortality as warfarin, and by extension provides proof of concept of LAA closure. LAA closure is an upfront treatment without the bleeding risks inherent to lifelong anticoagulation. As such, with long-term efficacy similar to anticoagulation without the need for chronic drug dependence, percutaneous transcatheter …

Transcatheter Mitral-Valve Repair in Patients with Heart Failure

BACKGROUND Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral‐valve repair may improve their clinical outcomes. METHODS At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate‐to‐severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline‐directed medical therapy. Patients were randomly assigned to transcatheter mitral‐valve repair plus medical therapy (device group) or medical therapy alone (control group). The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow‐up. The primary safety end point was freedom from device‐related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 88.0%. RESULTS Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient‐year in the device group as compared with 67.9% per patient‐year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001). The rate of freedom from device‐related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%; P<0.001 for comparison with the performance goal). Death from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001). CONCLUSIONS Among patients with heart failure and moderate‐to‐severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline‐directed medical therapy, transcatheter mitral‐valve repair resulted in a lower rate of hospitalization for heart failure and lower all‐cause mortality within 24 months of follow‐up than medical therapy alone. The rate of freedom from device‐related complications exceeded a prespecified safety threshold. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079.)

EVEREST II REALISM - A CONTINUED ACCESS STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE MITRACLIP DEVICE: ANALYSIS OF RESULTS THROUGH 1 YEAR

EVEREST II REALISM is a prospective, multi-center, continued access study to collect data on “real world” use of MitraClip in both high risk (HR) and non-high risk (NHR) patients. Preliminary 1-year outcomes are presented.nnHR was defined as STS score ≥12% or pre-specified risk factors. As of

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification

AimsnWe sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)].nnnMethods and resultsnFrom the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0u2009±u20097.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; Pu2009<u20090.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; Pu2009<u20090.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; Pu2009<u20090.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; Pu2009<u20090.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; Pu2009=u20090.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30u2009days (34.5% vs. 9.9% vs. 6.2%; log-rank Pu2009<u20090.001) and 1u2009year (62.8% vs. 30.6% vs. 14.0%; log-rank Pu2009<u20090.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; Pu2009=u20090.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; Pu2009<u20090.001].nnnConclusionnThe TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.