Gabriel Maluenda

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.

Balloon aortic valvuloplasty for severe aortic stenosis as a bridge to transcatheter/surgical aortic valve replacement

Objectives: This study aimed to determine success‐ and complication rates after balloon aortic valvuloplasty (BAV) and the outcome of BAV as a standalone therapy versus BAV as a bridge to transcatheter/surgical aortic valve replacement (T/SAVR). Background: The introduction of transcatheter aortic valve replacement (TAVR) has led to a revival in BAV as treatment for patients with severe aortic stenosis. Methods: A cohort of 472 patients underwent 538 BAV procedures. The cohort was divided into two groups: BAV alone 387 (81.9%) and BAV as a bridge 85 (18.1%) to (n = 65, TAVR; n = 20, surgery). Clinical, hemodynamic, and follow‐up mortality data were collected. Results: There was no significant difference between the two groups in mean age (81.7 ± 8.3 vs. 83.2 ± 10.9 years, P = 0.18), society of thoracic surgeons score (13.1 ± 6.2 and 12.4 ± 6.4, P = 0.4), logistic EuroSCORE (45.4 ± 22.3 vs. 46.9 ± 21.8, P = 0.43), and other comorbidities. The mean increase in aortic valve area was 0.39 ± 0.25 in the BAV alone group and 0.42 ± 0.26 in the BAV as a bridge group, P = 0.33. The decrease in mean gradient was 24.1 ± 13.1 in the BAV alone group vs. 27.1 ± 13.8 in the BAV as a bridge group, P = 0.06. During a median follow up of 183 days [54–409], the mortality rate was 55.2% (n = 214) in the BAV alone group vs. 22.3% (n = 19) in the BAV as a bridge group during a median follow‐up of 378 days [177–690], P < 0.001. Conclusion: In high‐risk patients with aortic stenosis and temporary contraindications to SAVR/TAVR, BAV may be used as a bridge to intervention with good mid‐term outcomes.

Coronary Obstruction in Transcatheter Aortic Valve-in-Valve Implantation Preprocedural Evaluation, Device Selection, Protection, and Treatment

The majority of surgical heart valves being implanted during the past decade are bioprosthetic, tissue valves with limited durabiity.1–4 These tissue valves have limited durability.2–4 Recently, implantation of transcatheter valves inside failed surgically implanted aortic bioprostheses (valve-in-valve [VIV]) has been reported as a less-invasive alternative to repeat surgery.5 Although procedural success is achieved in the great majority of patients, this therapy is associated with several potential risks, including ostial coronary occlusion.6,7 Coronary obstruction is a serious procedural complication, associated with a high mortality rate.5–9 Importantly, during the recent years, several preprocedural and technical aspects have been described to identify those patients at increased risk. Therefore, in such high-risk patients, a modified VIV procedure, redo surgical valve replacement, or medical treatment only may be considered (Figure 1). We herein review the mechanisms of coronary obstruction, the optimal identification of patients at risk for coronary obstruction, and further describe technical considerations for preventing and treating this life-threatening complication. Figure 1. Flow chart of suggested evaluation and treatment of a candidate for aortic Valve-in-Valve implantation. (1) Details in Tables 1 to 3. (2) According to imaging and clinical characteristics. (3) Balloon valvuloplasty will optimally model the risk for coronary occlusion using a balloon size similar to the transcatheter heart valve (THV) device to be implanted. The risk for hemodynamic instability after valvuloplasty secondary to worsening regurgitation should be considered, and a THV device should be prepared for rapid implantation if needed. (4) If the patient is hemodynamically stable after valvuloplasty and the risk for left main occlusion seems high, considerations for redo surgery or medical treatment only could be made, otherwise coronary protection is advocated using a wire and a stent. (5) Consider using a retrievable THV device or a device with …

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.

Prognostic Value of Hemoglobin A1C Levels in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention With Stent Implantation

The optimal glycosylated hemoglobin (HbA1C) target in diabetic patients is a subject of ongoing controversy that may be especially pertinent in diabetic patients with coronary artery disease. This study aimed to determine the prognostic value of preprocedural HbA1C levels in diabetic patients undergoing percutaneous coronary intervention (PCI) with stent implantation. From 2002 to 2007, a cohort of 952 consecutive diabetic patients underwent PCI with stent implantation in our center. We compared patients with a normal preprocedural HbA1C (< or = 7%, n = 429) with patients with an increased HbA1C (>7%, n = 523). One-year rate of major adverse cardiovascular events (MACEs) including death, myocardial infarction, and target vessel revascularization was indexed. Baseline characteristics were similar between groups, except for body mass index, which was higher in the high HbA1C group (32.2 vs 31.2 kg/m(2), p = 0.03). Patients in the high HbA1C group were more likely insulin dependent (45.5% vs 26.3%, p <0.001). Rates of MACEs were similar (23.7% vs 20.8%) in the high HbA1C and low HbA1C groups (p = 0.45). By multivariate analysis, age, renal failure, clinical presentation as myocardial infarction, and history of congestive heart failure were independently associated with MACEs. In contrast, HbA1C was not associated with patient outcome. In conclusion, this study suggests that HbA1C is not a predictor of cardiac events in diabetic patients with advanced coronary artery disease. These results could explain, at least in part, recent findings of randomized clinical trials that suggest the absence of benefit in macrovascular complications of a strict glycemia control.