Cardiac catheterization, coronary intervention, and wait times for transcatheter aortic valve replacement.

OBJECTIVES: Prolonged wait times for transcatheter aortic valve replacement (TAVR) are associated with increased morbidity and mortality. The incidence and predictors of short TAVR wait times (STWT: defined as ≤ 30 days from referral to TAVR procedure) have not been defined. This study examined the impact of clinical characteristics, demographics, and pre-TAVR cardiac catheterization on wait times for TAVR. METHODS: This was a retrospective observational analysis of 831 patients with severe aortic stenosis undergoing TAVR from 2019 to mid-2022 at the University of Vermont Medical Center. Demographics, timing of treatment [stratified by COVID-19 onset (1 March 2020)], TAVR center travel distance, baseline clinical factors, and process-related variables were analyzed to determine univariate STWT predictors (P < 0.10). Multivariable analysis was performed to determine independent STWT predictors. RESULTS: Approximately 50% of TAVR patients in this study achieved a STWT. The proportion of patients with STWT was higher (54.7% vs. 45.2%; P = 0.008) after the onset of COVID-19 pandemic. STWT was not related to travel distance (P = 0.61). Patients with left ventricular ejection fraction (LVEF) > 60% were less likely to achieve STWT compared to patients with LVEF < 40% (OR 0.45, P = 0.003). Patients who required catheterization or percutaneous coronary intervention (PCI) before TAVR were significantly less likely to achieve STWT (OR 0.65, P = 0.01). CONCLUSION: TAVR wait times were not affected by the COVID-19 pandemic or single rural TAVR center travel distance. Sicker patients were more likely to achieve STWT while catheterization/PCI before TAVR was associated with longer wait times.

Gender related differences in predictors of vascular complications: role of vessel size and BMI.

Women undergoing cardiac catheterization have an increased risk of vascular complications (VC) compared to men. Whether this is due to gender differences in common femoral artery (CFA) anatomy remains unknown. Therefore, we examined angiographic features of CFA to identify differences in predictors of VC between the genders. A case control study design enrolled 59 (30 women and 29 men) consecutive patients with VC and 59 age, gender and procedure matched controls from 2004 to 2009. VC were defined as hematoma >6 cm, any access site related bleeding requiring transfusion or injury requiring mechanical intervention. Quantitative angiography was performed on all femoral angiograms. Univariate and multivariate regression was performed to define clinical and angiographic predictors of VC. Among all patients, cases had significantly lower BMI than controls (28.4 ± 7.7 vs. 32.0 ± 6.7, p ≤ 0.01) and were more than twice likely to have CFA reference vessel diameter <5.5 mm (p = 0.04). This finding was entirely driven by the inverse relationship between BMI, CFA and VC among women. On multivariate analysis, BMI was a potent predictor of VC (OR 0.94; 95 % CI 0.89-0.99; p = 0.04). When comparing men and women, BMI and CFA size were predictors of VC among women only. Among men, site of arteriotomy and diabetes mellitus predicted risk of VC. Smaller BMI correlates with smaller CFA diameter and both are predictive of increased risk of VC. This may explain the female predisposition to VC. Risk stratification for bleeding and VC should address these gender specific findings.

Two hour bivalirudin infusion after PCI for ST elevation myocardial infarction.

The standard of care for STEMI PCI for the past decade has been aspirin, clopidogrel, heparin, and a glycoprotein IIbIIIa receptor inhibitor (GPI). A bivalirudin strategy was shown to be superior to a GPI strategy in the HORIZONS AMI trial for net adverse clinical events (combined MACE and bleeding). An increased risk of acute stent thrombosis in the bivalirudin arm may have prevented broader adoption of bivalirudin for this indication. We hypothesized that acute stent thrombosis risk could be ameliorated by a 2 h infusion of bivalirudin following STEMI PCI. We implemented a multicenter, prospective registry for all STEMI patients in Vermont treated at a single PCI center. Each patient was routinely pre-loaded with dual antiplatelet therapy and 75% received an unfractionated heparin bolus prior to PCI. The utilization of bivalirudin bolus and continued 2 h infusion after PCI was routine with GPI bailout optional. 128 consecutive STEMI patients underwent primary PCI from October 1, 2008 to September 30, 2009. 92% of primary PCI patients received bivalrudin during and after the procedure with a 9% rate of bail out GPI. There was one case of probable or definite acute stent thrombosis (0.7%), and this single case occurred despite use of bailout GPI. Despite the prolonged infusion of bivalirudin, major bleeding occurred in only 1.7% of STEMI patients. In conclusion, prolonging bivalirudin for 2 h after STEMI PCI may be a promising method to alleviate acute stent thrombosis risk without losing the bleeding complication benefit of the bivalirudin strategy.

Angiographic predictors of vascular complications among women undergoing cardiac catheterization and intervention.

BACKGROUND: Bleeding and vascular complications remain more common in women than men undergoing invasive cardiovascular procedures. We determined the role of femoral angiographic variables in risk-stratifying women for vascular complications. METHODS: Between 2004-2009, all major bleeding and vascular complications among women undergoing diagnostic or interventional cardiovascular procedures were identified at a single center. Thirty consecutive female patients (major bleeding or vascular complication) were then age- and procedure-matched to 90 controls (no vascular complications). Quantitative femoral angiography was performed on all cases and controls. RESULTS: Smaller minimum luminal diameter was a strong univariate predictor of vascular complications in women (odds ratio [OR] 0.65; 95% confidence interval [CI] 0.47-0.90; p = 0.009), while site of arteriotomy was not predictive of complications. The prognostic significance of smaller femoral lumen diameter was mildly attenuated after adjusting for the predictive factor of smaller patient body size, even after adjusting for the predictive factor of smaller patient body size. Finally, multivariable modeling suggests that utilization of vascular closure devices (OR 0.26, 95% CI 0.07-0.96; p = 0.04) may be protective in women. CONCLUSIONS: Women with smaller femoral arteries are at significantly higher risk for bleeding and vascular complications than women with larger femoral arteries. Risk stratification for bleeding complications among women should account for clinical, pharmacologic and femoral angiographic factors.

Frequency and safety of switching antithrombin therapy at a regional PCI center.

The impact of switching antithrombin therapy in patients presenting with acute coronary syndromes (ACS) and undergoing percutaneous intervention (PCI) has varied in clinical trials. We sought to assess the incidence and safety of switching antithrombin therapy in ACS patients undergoing PCI at a regional medical center. All patients with ACS undergoing PCI (n = 728) during a specified time period in 2005 and 2007 were identified. Patients who were switched to the antithrombin bivalirudin were defined as the "switch" group (n = 323) and all others were defined as the "consistent" therapy group (n = 405). Primary endpoints were major adverse cardiac event (MACE) (death, MI or urgent revascularization), major bleeding and net adverse clinical event (NACE) (MACE or major bleeding). Multivariate analysis was performed to determine if switching antithrombotic therapy predicted primary outcomes. Among 728 patients undergoing PCI for ACS, 44% were switched to bivalirudin. Switch patient were more likely to be transfers from outside hospitals, older, female, and diabetic. Angiographic characteristics were similar in the two groups. Switch patients had a similar incidence of MACE (7 vs. 8%, P = 0.72), major bleeding (2 vs. 2%) and NACE (9 vs. 10%, P = 0.51) when compared to those who received consistent therapy. On multivariate analysis, switching did not predict MACE (OR = 0.94, 95% CI = 0.53-1.67, P = 0.84) or NACE (OR = 0.82, 95%CI = 0.48-1.41, P = 0.47). In a regional clinical practice of patients presenting with ACS and undergoing PCI, switching of antithrombin therapy to bivalirudin is a common practice and patient who are switched have similar outcomes compared to patients who receive consistent therapy.

Consistent door-to-balloon times of less than 90 minutes for STEMI patients transferred for primary PCI.

BACKGROUND: Recent data from large national registries show that < 15% of patients with ST-elevation myocardial infarction (STEMI) transferred for primary percutaneous intervention (PCI) actually meet the door-to-balloon (D2B) goal of < or = 90 minutes, and only onethird achieve D2B times of < or = 120 minutes. We established a streamlined STEMI protocol to allow rapid transfer of STEMI patients for primary PCI to meet the ACC D2B goal of < or = 90 minutes in at least 75% of the patients. METHODS: From February 2007 to August 2008, 37 consecutive patients presenting with STEMI to a community hospital in Vermont were transferred 26 miles to the University of Vermont (UVM) for primary PCI. Three time intervals were evaluated: presentation to departure time at the referring hospital, transfer time and UVM PCI time (time from arrival to the cath lab to balloon time). Total D2B time was defined as presentation to the first hospital to first balloon inflation. RESULTS: The majority of transfers (69%) occurred off-hours. All patients received aspirin and clopidogrel and heparin pre-PCI. Median presentation to departure time at the STEMI referral hospital, total transfer and UVM PCI times were 26 (20, 33), 36 (34, 40) and 20 (16, 22) minutes, respectively. The median D2B time was 82 (77, 91) minutes, with 73% of patients achieving the goal D2B of < or = 90 minutes, and 94% achieving a D2B time of < or = 120 minutes. CONCLUSION: For patients in a rural setting who present with STEMI, transfer of approximately 30 miles for timely primary PCI can be achieved in nearly 75% of patients using a simplified streamlined protocol.

Extravascular closure for patients with high-risk femoral anatomy.

BACKGROUND: Vascular closure devices (VCDs) improve patient comfort and decrease time to ambulation. However, VCD studies have excluded patients with high-risk femoral artery anatomy; we examined the safety and efficacy of clip-based extravascular closure in this high-risk group. METHODS: We performed a prospective registry enrolling 98 consecutive patients undergoing diagnostic coronary angiography. Inclusion criteria were femoral artery calcification, moderate femoral artery stenosis, or non-femoral arterial sheath insertion. All patients underwent immediate vessel closure with the Starclose device (Abbott Vascular). Patients with severe femoral arterial disease or femoral arterial diameter < or = 4.0 mm were excluded. Hospital outcomes were assessed prospectively and femoral arterial stenosis was determined by quantitative angiography. RESULTS: Inclusion was mainly related to at least one of 3 main high-risk characteristics: moderate femoral arterial stenosis (30%), femoral arterial calcification (24%) or nonfemoral sheath insertion (46%). The average femoral stenosis was 35.3 +/- 5.1% among patients included for a significant femoral disease. There was a 100% procedural and 94% device success: 1 patient required manual compression for greater than or equal to 30 minutes. The average time from sheath removal to hemostasis was 0.76 +/- 1.3 minutes. Despite the higher-risk anatomy, there were no major vascular complications and only one minor vascular complication. The average time to ambulation was 78.1 +/- 47.3 minutes. CONCLUSIONS: In this prospective registry, the Starclose VCD was safe and effective for early ambulation of patients despite the presence of high-risk femoral arterial anatomy.