Manuel A. Gonzalez

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

OBJECTIVES This study aimed to determine the success, complications, and survival of patients after balloon aortic valvuloplasty (BAV). BACKGROUND The introduction of transcatheter aortic valve implantation (TAVI) BAV has led to a revival in the treatment of patients with severe aortic stenosis. METHODS A 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. RESULTS The 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). CONCLUSIONS Long-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.

Correlates and Causes of Death in Patients With Severe Symptomatic Aortic Stenosis Who Are Not Eligible to Participate in a Clinical Trial of Transcatheter Aortic Valve Implantation

Background— Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies. Methods and Results— From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group. Conclusion— Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.

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.

Comparison between Society of Thoracic Surgeons Score and logistic EuroSCORE for predicting mortality in patients referred for transcatheter aortic valve implantation

BACKGROUND The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI. METHODS The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 ± 8.1 years, and 394 (54.8%) were female. RESULTS The mean STS score was 11.5 ± 6.1, and the mean logistic EuroSCORE was 39.7 ± 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 ± 6.2 vs.10.0 ± 5.8 and 43.4 ± 23.1 vs. 37.5 ± 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE. CONCLUSION In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options.

Correlation between fractional flow reserve and intravascular ultrasound lumen area in intermediate coronary artery stenosis.

AIMS Fractional flow reserve (FFR) of <0.8 or 0.75 is currently used to guide revascularisation in lesions with intermediate coronary stenosis. We assessed whether there is an intravascular ultrasound (IVUS) measurement that can reliably be used to predict when patients should undergo intervention. METHODS AND RESULTS The analysis included 92 intermediate lesions (84 patients) located in vessel diameters >2.5 mm. Positive FFR was considered present at <0.8 and 0.75. IVUS minimum lumen area (MLA) was correlated to the FFR findings in intermediate lesions with 40-70% stenosis. The mean FFR value was 0.89 ± 0.08. Twenty-four patients (26.1%) had FFR <0.8; 17 (18.5%) <0.75. Positive correlations between FFR and IVUS measurements included MLA (r = 0.34, p<0.001), minimum lumen diameter (MLD) (r=0.31, p=0.004), lesion length (r=-0.5, p<0.001), and area stenosis (r=-0.31, p=0.01). There was no significant correlation between FFR and quantitative coronary angiography in MLD (r=0.19, p=0.06), diameter stenosis (r=0.08, p=0.4), or lesion length (r=-0.14, p=0.17). A receiver operating characteristic curve identified MLA <2.8 mm2 (sensitivity 79.7%, specificity 80.3%) as the best threshold value for FFR <0.75; and MLA <3.2 mm2 as best for FFR <0.8 (sensitivity 69.2%, specificity 68.3%). CONCLUSIONS Anatomic measurements of intermediate coronary lesions obtained by IVUS show a moderate correlation to FFR values, although they differ according to vessel size. IVUS MLA may be used as an alternative to FFR when assessing the need for intervention in intermediate coronary lesion. Vessel size, however, should always be taken into account.

Reliability of Prehospital Real-Time Cellular Video Phone in Assessing the Simplified National Institutes of Health Stroke Scale in Patients With Acute Stroke: A Novel Telemedicine Technology

Background and Purpose— The National Institutes of Health Stroke Scale (NIHSS) is the gold standard to assess patients with acute stroke. We aimed to examine the feasibility and reliability of prehospital real-time cellular video phone (VP) in performing the NIHSS. Methods— Forty physicians prospectively performed a simplified NIHSS (sNIHSS) on a standardized patient remotely using VP with the assistance of a bedside emergency medical technician and later performed a bedside examination. We tested the hypothesis that there is high reliability between these 2 methods. Physicians were timed and sNIHSS scores were recorded. Finally, physicians were asked to rate the VP technology. Results— A total of 480 pair comparisons of the sNIHSS scores between the VP and bedside examination were generated. After adjusting for the physicians specialty, level of training, and certification status, there was a strong positive linear correlation (r=0.97, P<0.01) between the 2 methods with high average physician reliability (0.99; 95% CI, 0.992 to 0.995). The mean sNIHSS scores using VP and bedside examination were not different (6.82±1.06 versus 6.63±0.98; P=0.08). The mean time to perform the sNIHSS using VP was approximately 38 seconds longer than the bedside examination (3.38±0.77 versus 2.93±0.83 minutes; P=0.006). Conclusions— The VP is a feasible, reliable, and timely tool with the potential for remotely assessing the sNIHSS for patients presenting with acute stroke and may expedite the initial evaluation and treatment strategies.

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

BACKGROUND Nuisance 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. METHODS Included 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. RESULTS After 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. CONCLUSION Nuisance 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

OBJECTIVES We sought to examine the effect of insurance type upon the likelihood of receiving a drug-eluting stent (DES). BACKGROUND Recent 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. METHODS Patients 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. RESULTS Among 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. CONCLUSIONS Insurance 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.