Kohei Wakabayashi

Complications and Outcome of Balloon Aortic Valvuloplasty in High-Risk or Inoperable Patients

OBJECTIVESnThis study aimed to determine the success, complications, and survival of patients after balloon aortic valvuloplasty (BAV).nnnBACKGROUNDnThe introduction of transcatheter aortic valve implantation (TAVI) BAV has led to a revival in the treatment of patients with severe aortic stenosis.nnnMETHODSnA cohort of 262 patients with severe aortic stenosis underwent 301 BAV procedures. Of these, 39 (14.8%) patients had ≥2 BAV procedures. Clinical, hemodynamic, and follow-up mortality data were collected.nnnRESULTSnThe cohort mean age was 81.7 ± 9.8 years, and the mean Society of Thoracic Surgeons and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13.3 ± 6.7 and 45.6 ± 21.6, respectively. BAV was performed as a bridge to TAVI or to surgical aortic valve replacement in 28 patients (10.6%) and for symptom relief in 234 (89.4%). The mean aortic valve area (AVA) increased from 0.58 ± 0.3 cm(2) to 0.96 ± 0.3 cm(2) (p < 0.001). Of these, 111 (45.0%) had final AVA >1 cm(2), and in 195 patients (79%), AVA increased by >40%. De novo BAV resulted in a higher mean increase in AVA 0.41 ± 0.24 cm(2) versus 0.28 ± 0.24 cm(2) in redo BAV (p = 0.003). Serious adverse events occurred in 47 patients (15.6%), intraprocedural death in 5 (1.6%), stroke in 6 (1.99%), coronary occlusion in 2 (0.66%), severe aortic regurgitation in 4 (1.3%), resuscitation/cardioversion in 5 (1.6%), tamponade in 1 (0.33%), and permanent pacemaker in 3 (0.99%). A vascular complication occurred in 21 patients (6.9%); 34 (11.3%) had a post-procedure rise in creatinine >50%; and 3 (0.99%) required hemodialysis. During median follow-up of 181 days, the mortality rate was 50% (n = 131). The mortality rate in the group with final AVA >1 cm(2) was significantly lower than in the group with final AVA of <1 cm(2) (36.4% vs. 57.9%, p < 0.001). Final AVA was associated with lower mortality (hazard ratio: 0.46, p = 0.03). BAV as a bridge to TAVI or surgical aortic valve replacement had a better outcome compared with BAV alone: mortality rate 7 (25%) versus 124 (52.9%), respectively (p < 0.0001).nnnCONCLUSIONSnLong-term survival is poor after BAV alone. BAV as a bridge to percutaneous or surgical aortic valve replacement is feasible, safe, and associated with better outcome than BAV alone.

Clinical profile, prognostic implication, and response to treatment of pulmonary hypertension in patients with severe aortic stenosis.

The incidence, correlates, and prognostic implications of pulmonary hypertension (PH) are unclear in patients with severe aortic stenosis (AS). We studied 509 patients with severe AS evaluated for transcatheter aortic valve implantation (TAVI). Patients were divided into groups based on pulmonary artery systolic pressure (PASP): group I, 161 (31.6%) with PASP <40 mm Hg; group II, 175 (34.3%) with PASP 40 to 59 mm Hg; and group III, 173 (33.9%) with PASP ≥ 60 mm Hg. Group III patients were more symptomatic and had higher creatinine levels and higher left ventricular end-diastolic pressure. Transpulmonary gradient was >12 mm Hg in 17 patients (10.5%), 31 patients (17.7%), and 80 patients (46.2%) in groups I through III, respectively. In a median follow-up of 202 days (73 to 446) mortality rates were 35 (21.7%), 69 (39.3%), and 85 (49.1%) in groups I through III, respectively (p <0.001). Immediately after TAVI, in patients with PASP >40 mm Hg there was significant decrease in PASP (63.1 ± 16.2 to 48.8 ± 12.4 mm Hg, p <0.0001), which remained at 1 year (50.1 ± 13.1 mm Hg, p = 0.04). After surgical aortic valve replacement there was a significant immediate decrease in PASP (66.1 ± 16.3 to 44.7 ± 14.2 mm Hg, p <0.0001), which persisted at 3 to 12 months (44.8 ± 20.1 mm Hg, p <0.001). In patients who underwent balloon aortic valvuloplasty, PASP decreased immediately after the procedure (63.2 ± 14.8 to 51.8 ± 17.1 mm Hg, p <0.0001), yet at 3 to 12 months pressure returned to baseline levels (57.4 ± 17.0 mm Hg, p = 0.29). In conclusion, patients with severe AS have a high prevalence of PH, and in patients with severe AS increased PASP is associated with increased mortality. Surgical aortic valve replacement and TAVI are effective treatments for these patients and result in a significant PASP decrease.

Relation of Proton Pump Inhibitor Use After Percutaneous Coronary Intervention With Drug-Eluting Stents to Outcomes

Recent evidence has shown that clopidogrel and proton pump inhibitors (PPIs) are metabolized by the same pathway and that patients taking both drugs have greater levels of platelet reactivity and more adverse outcomes than patients taking only clopidogrel. We sought to examine the effect of a PPI at discharge from the hospital after percutaneous coronary intervention with drug-eluting stents on the incidence of major adverse cardiac events (MACE) at 1 year. We compared 502 patients who were not prescribed a PPI at discharge and 318 patients who were prescribed a PPI. All patients were taking clopidogrel. We followed patients for 1 year with regard to MACE, including death, Q-wave myocardial infarction, target vessel revascularization, and stent thrombosis. We performed multivariate Cox regression to adjust for confounding variables, including compliance with clopidogrel, to assess the effect of a PPI at discharge on the 1-year outcomes. The baseline characteristics of patients discharged with a PPI were similar to those of patients discharged without a PPI. Univariate survival analysis of the outcomes showed a greater rate of MACE (13.8% vs 8.0%, p = 0.008) and overall mortality (4.7% vs 1.8%, p = 0.02) in the PPI group. After multivariate analysis, the adjusted MACE hazard ratio for PPI at discharge was 1.8 (95% confidence interval 1.1 to 2.7, p = 0.01). In conclusion, in patients undergoing percutaneous coronary intervention with drug-eluting stents and receiving clopidogrel, the prescription of a PPI at discharge was associated with a greater rate of MACE at 1 year.

Incidence, correlates, and clinical impact of nuisance bleeding after antiplatelet therapy for patients with drug-eluting stents

BACKGROUNDnNuisance bleeding (NB) after dual antiplatelet therapy (DAPT) is not well characterized despite its potential to impact patient compliance. We therefore aimed to evaluate the incidence, correlates, and clinical impact of NB after DAPT after drug-eluting stent (DES) implantation.nnnMETHODSnIncluded were 2,948 patients with DES implantation who were discharged on DAPT for 12 months. New bleeding classifications were used: alarming bleeding, internal bleeding, and NB.nnnRESULTSnAfter excluding patients with alarming bleeding (9 [0.3%]) and internal bleeding (128 [4.3%]), the 2,811 remaining patients were divided into 2 groups: those with NB (812 [28.9%]) and those without (1,999 [71.1%]). Patients with NB were significantly younger (63.0 +/- 11.4 vs 65.2 +/- 11.6 years, P < .001), were more often white (82.0% vs 69.6%, P < .001), had lower body mass indices (29.2 +/- 6.1 vs 29.8 +/- 6.0 kg/m(2), P = .01), and a lower prevalence of diabetes (25.5% vs 34.8%, P < .001) compared to those without NB. At 1 year, the rate of major adverse cardiac events was higher in the NB group compared to the nonbleeding group (77 [9.4%] vs 134 [6.7%], P = .02). In the NB group, 46 patients (5.7%) stopped 1 or both antiplatelet therapies. Thirty-five (4.3%) discontinued clopidogrel, 16 (2.0%) stopped aspirin, and 5 (0.61%) stopped both as a result of the reported NB. Multivariable analysis detected younger age, lower body mass index, white race, and without diabetes as correlates associated with NB while on clopidogrel therapy.nnnCONCLUSIONnNuisance bleeding is common in patients on prolonged DAPT post-DES implantation and can impact compliance. Nuisance bleeding appears to have important clinical implications and, if confirmed in prospective trials, should be added to the safety end points assessing new antiplatelet agents.

Insurance Type Influences the Use of Drug-Eluting Stents

OBJECTIVESnWe sought to examine the effect of insurance type upon the likelihood of receiving a drug-eluting stent (DES).nnnBACKGROUNDnRecent guidelines suggest that consideration of a patients resources should play a role in decisions to use DES. Previous studies have also documented disparities in both access to care and cardiovascular outcomes according to race, insurance, and socioeconomic status. The effect of insurance status upon the decision to use DES is unclear.nnnMETHODSnPatients undergoing percutaneous coronary intervention (PCI) with stenting from April 2003 to June 2009, the so-called DES era, were retrospectively analyzed. Multivariable logistic regression was performed separately for patients <65 years and patients > or =65 years, with receipt of > or =1 DES during PCI as the outcome variable of interest. Insurance type was categorized as private, Medicare, Medicaid, and uninsured, based upon the primary insurance at discharge. Data regarding duration of clopidogrel therapy at 1 month, 6 months, and 1 year was also collected.nnnRESULTSnAmong the 12,584 patients who underwent PCI with stenting, 6,157 (48.9%) had private insurance, 5,689 (45.2%) had Medicare, 467 (3.7%) had Medicaid, and 271 (2.2%) were uninsured at the time of hospital discharge. There were no significant differences by insurance type in duration of dual antiplatelet therapy at 1 year. Both multivariable logistic regressions showed that Medicaid patients (odds ratio [OR]: 0.60; 95% confidence interval [CI]: 0.46 to 0.78 for age <65 years; OR: 0.45; 95% CI: 0.24 to 0.85 for age > or =65 years) and patients without insurance (OR: 0.57; 95% CI: 0.42 to 0.78 for age <65 years; OR: 0.20; 95% CI: 0.05 to 0.86 for age > or =65 years) were less likely to receive DES.nnnCONCLUSIONSnInsurance status has a significant impact upon the decision to use DES. Efforts to address this disparity should focus on the patient-provider level.

Impact of Chronic Obstructive Pulmonary Disease on Acute-Phase Outcome of Myocardial Infarction

Several reports have alluded to the adverse effect of chronic obstructive pulmonary disease (COPD) on long-term prognosis of patients with myocardial infarction (MI). Little information is available, however, regarding the effects of a decrease in cardiopulmonary reserve imposed by COPD on in-hospital outcome of acute MI. This study aimed to evaluate the impact of COPD on acute-phase outcome of patients with acute MI. From a cohort of 3,249 consecutive patients with ST-elevation MI who underwent primary or rescue percutaneous coronary intervention, 365 patients were identified as having coexistent COPD. Their clinical presentation and in-hospital outcome were compared to those of 2,884 patients without COPD. The primary end point was a composite of in-hospital death or cardiogenic shock on presentation. Patients with COPD were older (p <0.001), more often women (p <0.001), and smokers (p <0.001). They had higher prevalence of chronic renal insufficiency (p <0.001), systemic hypertension (p = 0.001), and diabetes mellitus (p = 0.01). Patients with COPD had higher rates of the composite end point of death or cardiogenic shock (p <0.0001). After multivariate analysis, COPD remained a strong independent predictor of the composite end point of death or cardiogenic shock (p = 0.008). In conclusion, COPD is a very strong predictor of hemodynamic compromise resulting in death or cardiogenic shock in patients presenting with ST-elevation MI. This observation suggests that hemodynamic and pulmonary consequences of COPD decrease the capacity of the circulatory system to adjust to the effects of acute MI. Recognition of the potential for combined therapy is vital.

Effect of Insurance Type on Adverse Cardiac Events After Percutaneous Coronary Intervention

Previous studies have documented disparities in both access to invasive cardiovascular procedures and outcomes in patients with Medicaid, Medicare, or no insurance. Outcomes by insurance have yet not been examined in a percutaneous coronary intervention (PCI) population. Data from patients undergoing PCI from June 2000 to June 2009 were retrospectively analyzed. Insurance was categorized as private, Medicare, Medicaid, and uninsured, according to the primary insurance at discharge. The outcome variable of interest was major adverse cardiac events (a composite of death, Q-wave myocardial infarction, and target vessel revascularization) at 1 year. Multivariable Cox regression analysis was stratified according to age <65 and ≥65 years. Of the 13,573 patients who had undergone PCI, 6,653 (49.0%) had private insurance, 6,150 (45.3%) had Medicare, 486 (3.6%) had Medicaid, and 284 (2.1%) were uninsured. Of the patients <65 years old, Medicaid (hazard ratio [HR] 1.59, 95% confidence interval [CI] 1.04 to 2.43), Medicare (HR 2.18, 95% CI 1.58 to 2.99), and no insurance (HR 2.41, 95% CI 1.36 to 4.27) were associated with greater rates of adjusted major adverse cardiac events at 1 year compared with private insurance. Of the patients ≥65 years old, only Medicaid (HR 3.07, 95% CI 1.09 to 8.61) was associated with a greater rate of adjusted major adverse cardiac events at 1 year. In conclusion, patients with government-sponsored insurance and no insurance have worse cardiovascular outcomes than patients with private insurance after PCI at 1 year. This implies that the provision of health insurance alone might not have a dramatic effect on cardiovascular outcomes after PCI.

Utility of Radiologic Review for Noncardiac Findings on Multislice Computed Tomography in Patients With Severe Aortic Stenosis Evaluated for Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) without replacement requires precise knowledge of the anatomic dimensions and physical characteristics of the peripheral vasculature and aortic valve annulus at the insertion of the aortic valve leaflet and root at the level of the sinus of Valsalva. Multislice computed tomography (CT) allows detailed and precise assessment of the anatomic variables. Noncardiovascular structures are also amenable to assessment by CT. Of the 394 patients screened for TAVI, 259 (65.7%) had non-contrast CT to evaluate chest anatomy and contrast CT to evaluate ilio-femoral anatomy. Significant noncardiac findings were defined as those requiring immediate evaluation or intervention or additional clinical or radiologic follow-up. Noncardiovascular findings known before CT were not included. Of the 259 patients, 105 (40.5%) were men. The mean age was 82.3 +/- 8.1 years. New, significant noncardiovascular findings were found in 89 (34.3%) and malignancy in 11 (4.2%) patients. Insignificant noncardiovascular findings were identified in 222 patients (85.7%). Signs of fluid retention were noted on CT in 105 patients (40.5%), with pleural effusion in 100 (38.6%), ascites in 17 (6.5%), and pericardial effusion in 14 (5.4%). Important peripheral vascular disease was found in 98 patients (37.8%), resulting in exclusion of 49 (19.1%) from TAVI using the transfemoral approach. An aortic aneurysm was found in 10 patients (3.8%) and a porcelain aorta (heavily calcified ascending aorta) in 19 (7.3%). In conclusion, malignancy and other noncardiovascular abnormalities are often found in patients who undergo CT for evaluation for TAVI. Populations must be meticulously examined to ensure that important findings are not missed.

Body mass index and bleeding complications after percutaneous coronary intervention: Does bivalirudin make a difference?

BACKGROUNDnThe association between obesity and bleeding after percutaneous coronary intervention (PCI) is not well defined. We investigated the impact of body mass index (BMI) on PCI-related bleeding, and whether bivalirudin, compared to heparin, used as PCI anticoagulant modifies this relationship.nnnMETHODSnFrom 2000 to 2009, 16,783 patients who underwent PCI were grouped according to 6 BMI groups: underweight (<18.5 kg/m(2)), normal weight (18.5-24.9 kg/m(2)), overweight (25-29.9 kg/m(2)), class I (30-34.9 kg/m(2)), class II (35-39.9 kg/m(2)), and class III obesity (> or =40 kg/m(2)). Bivalirudin was used in 11,433 patients and heparin in 5,350. In-hospital major bleeding (hematocrit drop > or =15% or gastrointestinal bleeding) and need for transfusion rates were collected.nnnRESULTSnThe incidence of major bleeding varied significantly throughout the BMI spectrum (5.6% vs 2.5% vs 1.9% vs 1.6% vs 2.1% vs 1.9%, respectively, from underweight to class III obese patients, P < .001). The incidence of transfusion across BMI followed the same reverse J-shape curve (10.9% vs 6.6% vs 3.6% vs 3.4% vs 3.8% vs 5.6%, P < .001). After adjustment for potential confounding factors, underweight patients had neither an increased risk for major bleeding nor an increased risk for transfusion compared with normal weight patients. Class I obese patients had a lower risk of major bleeding (odds ratio [OR] 0.68 [95% CI 0.48-0.97]). Overweight, class I, and II obese patients had a lower risk of transfusion (respectively, OR 0.68 [0.55-0.84], 0.68 [0.53-0.87], and 0.66 [0.48-0.92]). The highest BMI patients had neither an increased risk for major bleeding (class II and III obesity) nor an increased risk for transfusion (class III obesity). The same reverse J-shaped relationship to BMI seen in the overall population for the raw incidence of major bleeding was found when the population was divided according to type of anticoagulant used as follows: bivalirudin or heparin. Likewise, the need for transfusion relationship to BMI is not altered by bivalirudin use.nnnCONCLUSIONnThe better outcome for bleeding seen in patients in the middle of the BMI spectrum suggests the existence of a bleeding obesity paradox, which persists after adjustment by confounding factors and exists irrespective of the anticoagulant used.

Association Between Bleeding Severity and Long-Term Mortality in Patients Experiencing Vascular Complications After Percutaneous Coronary Intervention

Vascular complications (VCs) occur in 3% to 8% of percutaneous coronary interventions (PCIs). However, only a portion of patients who experience VCs bleed significantly. The aim of this study was to assess the covariates associated with the amount of blood loss in patients experiencing postprocedural VCs as well as the effect of the degree of blood loss on long-term mortality. Overall, 7,718 unselected patients who underwent PCI through femoral access were evaluated. Those experiencing VCs were identified and stratified with regard to the degree of hematocrit (HCT) decrease after the procedure. In total, 444 patients (5.8%) had VCs. Compared to those without VCs, patients with VCs were older and had more extensive co-morbidities. Severe blood loss was most frequent in those who had vascular perforation requiring surgical repair or in those who had retroperitoneal bleeding. Overall, <25% of patients with hematoma had severe blood loss. The raw 1-year mortality was doubled in patients with minimal or moderate HCT decrease and was tripled in those with severe decreases in HCT. Similarly, the rate of definite stent thrombosis was tripled in patients with VCs and moderate or severe decreases in HCT. After adjustment, only patients with VCs and the greater HCT decreases had an increased risk for death at 1 year (hazard ratio 1.80, 95% confidence interval 1.03 to 3.14). Independent predictors of severe HCT decrease included age, female gender, glycoprotein IIb/IIIa inhibitor use, and activated clotting time peak. Bivalirudin and closure devices were independently associated with less frequent severe HCT decrease. In conclusion, VCs do not entail an increased risk for death at 1 year unless associated with severe blood loss. The use of bivalirudin and closure devices seems to reduce the risk for such complications.