Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study.

BACKGROUND: The 3M-TAVR trial (3M-Transcatheter Aortic Valve Replacement) demonstrated the feasibility and safety of next-day hospital discharge after transfemoral TAVR with implementation of a minimalist pathway. However, the economic impact of this approach is unknown. Therefore, we evaluated costs for patients undergoing minimalist TAVR compared with conventional TAVR. METHODS: We used propensity matching to compare resource utilization and costs (from a US health care system perspective) for patients in the 3M-TAVR trial with those for transfemoral TAVR patients enrolled in the contemporaneous S3i trial (PARTNER SAPIEN-3 Intermediate Risk). Procedural costs were estimated using measured resource utilization for both groups. For the S3i group, all other costs through 30-day follow-up were assessed by linkage with Medicare claims; for 3M, these costs were assessed using regression models derived from S3i cost and resource utilization data. RESULTS: After 1:1 propensity matching, 351 pairs were included in our study (mean age 82, mean Society of Thoracic Surgery risk score 5.3%). There were no differences in death, stroke, or rehospitalization between the 3M-TAVR and S3i groups through 30-day follow-up. Index hospitalization costs were $10 843/patient lower in the 3M-TAVR cohort, driven by reductions in procedure duration, anesthesia costs, and length of stay. Between discharge and 30 days, costs were similar for the 2 groups such that cumulative 30-day costs were $11 305/patient lower in the 3M-TAVR cohort compared with the S3i cohort ($49 425 versus $60 729, 95% CI for difference $9378 to $13 138; P<0.001). CONCLUSIONS: Compared with conventional transfemoral TAVR, use of a minimalist pathway in intermediate-risk patients was associated with similar clinical outcomes and substantial in-hospital cost savings, which were sustained through 30 days. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02287662.

The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study.

OBJECTIVES: The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway. BACKGROUND: Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines. METHODS: Patients were enrolled from 6 low-volume (<100 TAVR/year), 4 medium-volume, and 3 high-volume (>200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR. RESULTS: Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15). CONCLUSIONS: Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.

Reperfusion Times for Radial Versus Femoral Access in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: Observations From the Cardiac Care Network Provincial Primary PCI Registry.

BACKGROUND: Radial access is associated with less bleeding and vascular complications. However, it may delay reperfusion during primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction. METHODS AND RESULTS: A provincial database prospectively collected clinical and procedural characteristics for all urgent percutaneous coronary intervention procedures performed between June 2010 and September 2011 in Ontario for ST-segment-elevation myocardial infarction, including time of arrival in the catheterization laboratory and time of first balloon inflation. After excluding patients with cardiogenic shock, with previous bypass surgery, or who received fibrinolysis, 2947 patients were included in the analysis. Propensity score matching was used to minimize difference in clinical characteristics between radial and femoral access procedures. Predictors of radial access included younger age and male sex. After propensity score matching, the median time from arrival in the cardiac catheterization laboratory to first balloon was 27 minutes (25th%-75th%, 21-34) for the femoral group and 30 minutes (25th%-75th %, 24-39) for the radial group (P<0.001). When hospitals were stratified based on the proportion of primary percutaneous coronary intervention cases that were performed using radial access, there was no difference in treatment times between radial and femoral access in the tercile of hospitals that used radial access most frequently. There were no significant differences in the rates of death or myocardial infarction at 30 days. CONCLUSIONS: This contemporary multicenter registry demonstrates that the time to first balloon inflation is slightly longer with radial access than with femoral access, although the 3 minute difference is unlikely to be clinically relevant. There is no difference in treatment times at hospitals that frequently use radial access for primary percutaneous coronary intervention. Short-term mortality and reinfarction rates are similar with radial and femoral access.

Traditional cardiovascular risk factors and the presence of obstructive coronary artery disease in men and women.

BACKGROUND: Extensive research has demonstrated the importance of traditional cardiovascular risk factors in predicting acute coronary events. Our main objective was to evaluate the relationship between traditional risk factors and the presence of obstructive coronary artery disease (CAD), and to explore potential differences in men vs women. METHODS: An observational study was conducted in a population-based cohort of stable patients who underwent cardiac catheterization in Ontario, Canada. We examined the relationship of diabetes, hypertension, hyperlipidemia, and smoking with the presence of obstructive CAD in men and women using multivariable logistic regression models. RESULTS: Of the 46,490 patients who were included in our study, 61.2% were men and 38.8% were women. We found that 97% of patients with obstructive CAD had at least 1 conventional cardiovascular risk factor. The adjusted odds ratios (ORs) for obstructive CAD in women with diabetes (OR, 1.51), hypertension (OR, 1.38), and smoking (OR, 1.39) were statistically significantly greater than in men (OR, 1.20 for diabetes; OR, 1.08 for hypertension; OR, 1.14 for smoking; P < 0.001). The sex difference was even greater for patients with multiple risk factors. For example, the association with obstructive CAD in women with 4 cardiac risk factors (OR, 4.30; 95% confidence interval, 3.49-5.28) was almost doubled compared with men (OR, 2.26; 95%confidence interval, 1.99-2.57; P < 0.001). CONCLUSIONS: Almost all patients with stable CAD undergoing cardiac catheterization had at least 1 traditional cardiac risk factor. Importantly, the association between multiple cardiac risk factors and the presence of obstructive CAD is substantially stronger in women than men.

Risk of elective major noncardiac surgery after coronary stent insertion: a population-based study.

BACKGROUND: Guidelines recommend that noncardiac surgery be delayed until 30 to 45 days after bare-metal stent implantation and 1 year after drug-eluting stent implantation. METHODS AND RESULTS: We used linked registry data and population-based administrative health care databases to conduct a cohort study of 8116 patients (≥40 years of age) who underwent major elective noncardiac surgery in Ontario, Canada between 2003 and 2009, and received coronary stents within 10 years before surgery. Approximately 34% (n=2725) underwent stent insertion within 2 years before surgery, of whom 905 (33%) received drug-eluting stents. For comparison, we assembled a separate cohort of 341 350 surgical patients who had not undergone coronary revascularization. The primary outcome was 30-day major adverse cardiac events (mortality, readmission for acute coronary syndrome, or repeat coronary revascularization). The overall rate of 30-day events in patients with coronary stents was 2.1% (n=170). When the interval between stent insertion and surgery was <45 days, event rates were high for bare-metal (6.7%) and drug-eluting (20.0%) stents. When the interval was 45 to 180 days, the event rate for bare-metal stents was 2.6%, approaching that of intermediate-risk nonrevascularized individuals. Adjusted analyses suggested that event rates were increased if this interval exceeded 180 days. For drug-eluting stents, the event rate was 1.2% once the interval exceeded 180 days, approaching that of intermediate-risk nonrevascularized individuals. CONCLUSIONS: The earliest optimal time for elective surgery is 46 to 180 days after bare-metal stent implantation or >180 days after drug-eluting stent implantation.

Radial artery access as a predictor of increased radiation exposure during a diagnostic cardiac catheterization procedure.

OBJECTIVES: We sought to determine whether radial artery access is associated with increased radiation exposure during cardiac catheterization and whether this relationship differs between operators, after adjustment for clinical and patient characteristics associated with greater radiation exposure. BACKGROUND: Although previous studies have demonstrated a relationship between radial access and increased radiation exposure to the patient during fluoroscopy-guided cardiac procedures, such studies did not account for differences in operator technique or clustering of patients, procedure complexity, or patient size. Those studies included data from few operators. METHODS: Data were collected prospectively on 5,954 diagnostic cardiac catheterizations performed at a tertiary cardiac center. A multilevel regression analysis was used to determine the relationship between radial artery access and radiation exposure. RESULTS: After adjustment for multiple factors, radial access was associated with increased exposure (beta = 0.22, p < 0.0001) when compared with the use of femoral access, as measured using the logarithmically transformed air kerma (LogAK). On average, radial access accounted for a 23% increase in measured AK. This was consistent between operators. There were observed differences in the mean LogAK between operators (p = 0.0158), as well as substantial variation in measured LogAK between patients within each operator's practice (p < 0.001). CONCLUSIONS: Radial artery access cardiac catheterization was associated with increased radiation exposure to the patient when compared with femoral access. The measured AK was still far below the threshold for deterministic effects in most patients studied. Observed variations in AK between and within operators may point to better opportunities to reduce exposure.

Transcatheter aortic valve implantation in patients with bicuspid aortic valve stenosis.

OBJECTIVES: We evaluated transcatheter aortic valve implantation (TAVI) in high-risk patients with bicuspid aortic valve (BAV) stenosis. BACKGROUND: TAVI shows promise in the treatment of severe stenosis of triscupid aortic valves, especially in high-risk patients. However, BAV stenosis has been considered a contraindication to TAVI. METHODS: Eleven patients (age 52 to 90 years) with symptomatic severe BAV stenosis underwent TAVI at 3 Canadian tertiary hospitals between May 2006 and April 2010. All patients were considered high risk for surgical aortic valve replacement. Edwards-SAPIEN transcatheter heart valves (Edwards Lifesciences, Inc., Irvine, California) were used. Transfemoral or transapical access was selected, depending on the adequacy of femoral access. RESULTS: Access was transfemoral in 7 patients and transapical in 4 patients. There were no intraprocedural complications. Significant symptomatic and hemodynamic improvement was observed in 10 of 11 patients. Baseline aortic valve area of 0.65 ± 0.17 cm(2) and mean transaortic pressure gradient of 41 ± 22.4 mm Hg were improved to 1.45 ± 0.3 cm(2) and 13.4 ± 5.7 mm Hg, respectively. Two patients had moderate perivalvular leaks. At the 30-day follow-up there were 2 deaths due to multisystem failure in 2 transapical patients. In 1 patient an undersized, suboptimally positioned, unstable valve required late conversion to open surgery. CONCLUSIONS: TAVI in selected high-risk patients with severe BAV stenosis can be successfully performed with acceptable clinical outcomes but will require further evaluation.

Long-term outcomes with paclitaxel-eluting stents versus bare metal stents in everyday practice: a Canadian experience.

BACKGROUND: In randomized trials, paclitaxel-eluting stents (PES) are superior to bare metal stents (BMS) in reducing target lesion revascularization (TLR). However, recent reports suggest there may be an increase in late stent thrombosis with long-term follow-up in PES-treated patients. METHODS: Prospectively collected data from a regional cardiac referral centre were analyzed to compare PES versus BMS in all consecutive patients undergoing percutaneous coronary intervention from April 2003 to March 2004. Outcomes included combined death, myocardial infarction and clinically driven TLR, as well as stent thrombosis at four years follow-up. RESULTS: A total of 512 patients were treated with PES and 722 patients with BMS. At four years, there was 92% follow-up in both groups. The composite outcome of death, myocardial infarction and TLR was 13.9% in the PES group compared with 20% in the BMS group (P=0.01). This difference was primarily driven by the reduction in TLR in the PES cohort (3.9% versus 8%, P<0.01). The rate of definite stent thrombosis was 1.6% in the PES group compared with 0.4% in the BMS group (P=0.03). CONCLUSION: While PES offers an absolute 4.1% reduction in clinically driven TLR at four years, there is an associated increased risk of stent thrombosis. Further long-term studies addressing clinical outcomes including stent thrombosis with PES versus BMS are required to clarify this risk/ benefit balance.

Radiation dose in interventional cardiology procedures: urgent need for monitoring dose and establishing diagnostic reference levels.

The use of fluoroscopy in interventional cardiology procedures may expose patients to levels of radiation that manifest in unintended outcomes. Such outcomes may include skin injury and cancer. Currently, there is limited understanding of the magnitude of dose administered in an individual procedure. Canada does not have a formal policy for monitoring and recording the radiation dose administered to patients. This article reviews existing American, European and international policies for both monitoring administered radiation dose and patient follow-up. As a subsequent focus, this article presents the process for setting benchmarks for optimizing administered dose in the Hamilton Health Sciences Heart Investigation Unit.

Radial versus femoral access for emergent percutaneous coronary intervention with adjunct glycoprotein IIb/IIIa inhibition in acute myocardial infarction--the RADIAL-AMI pilot randomized trial.

BACKGROUND: Transradial percutaneous coronary intervention (PCI) results in fewer vascular complications, earlier ambulation, and improved patient comfort. Limited data exist for radial access in acute myocardial infarction, where reperfusion must occur quickly. METHODS: In a multicenter pilot trial, 50 patients with myocardial infarction requiring either primary or rescue PCI were randomized to radial or femoral access. All operators had previously performed at least 100 transradial cases. Procedure times were prospectively recorded. RESULTS: Thrombolysis was used in 66% of the cases and glycoprotein IIb/IIIa inhibitors in 94%. Crossover from radial to femoral access was required in one case. Percutaneous coronary intervention was performed in 47 patients, with stenting in 45. One procedural failure occurred with radial access because of inability to cross the occlusion. The time from local anesthesia to first balloon inflation was 32 (25th percentile 26, 75th percentile 38) minutes for radial access and 26 (22, 33) minutes for femoral access (P = .04). There were no significant differences in contrast use or fluoroscopy time. No patient experienced major bleeding or required transfusion. Doppler studies demonstrated 2 asymptomatic radial occlusions and 2 pseudoaneurysms (1 from each group). One patient in the femoral group died 2 days after PCI. At 30 days, there were no strokes or reinfarctions and no patient required bypass surgery or repeat PCI. CONCLUSIONS: Primary and rescue PCI can be performed with high success rates using either radial or femoral access. Although radial access was associated with a longer time to first balloon inflation, the difference was small and likely not clinically significant. In patients without shock, major bleeding and vascular complications are infrequent with either access site despite the high use of thrombolysis and glycoprotein IIb/IIIa inhibitors.