Cinzia Marrozzini

Acute kidney injury following transcatheter aortic valve implantation: incidence, predictors and clinical outcome

BACKGROUND Limited data exist on renal complications of transcatheter aortic valve implantation (TAVI) within a comprehensive program using different valves with transfemoral, transapical, and trans-subclavian approach. METHODS Prospective single-center registry of 102 consecutive patients undergoing TAVI using both approved bioprostheses and different access routes. The main objective was to assess the incidence, predictors and the clinical impact of acute kidney injury (AKI). AKI was defined according to the valve academic research consortium (VARC) indications. RESULTS Mean age was 83.7 ± 5.3 years, logistic EuroSCORE 22.6 ± 12.4%, and STS score 8.2 ± 4.1%. Chronic kidney disease at baseline was present in 87.3%. Periprocedural AKI developed in 42 patients (41.7%): 32.4% stage 1, 4.9% stage 2 and 3.9% stage 3. The incidence of AKI was 66.7% in transapical, 30.3% in transfemoral, and 50% in trans-subclavian procedures. The only independent predictor of AKI was transapical access, with a hazard ratio (HR) between 4.57 and 5.18 based on the model used. Cumulative 1-year survival was 88.2%. At Cox regression analysis, the only independent predictor of 30-day mortality was diabetes mellitus (HR 7.05, 95% CI 1.07-46.32; p=0.042), whilst the independent predictors of 1-year death were baseline glomerular filtration rate<30 mL/min (HR 5.74, 95% CI 1.42-23.26; p=0.014) and post-procedural AKI 3 (HR 8.59, 95% CI 1.61-45.86, p=0.012). CONCLUSIONS TAVI is associated with a high incidence of AKI. Although in the majority of the cases AKI is of mild entity and reversible, AKI 3 holds a strong negative impact on 1-year survival. The incidence of AKI is higher with transapical access.

Relevance of cytomegalovirus infection and coronary-artery remodeling in the first year after heart transplantation: a prospective three-dimensional intravascular ultrasound study.

Background. Transplant coronary artery disease (TxCAD) is a major cause of long-term mortality after heart transplantation. Although vascular remodeling has been implicated in the pathophysiology of TxCAD, its determinants remain unknown. Methods. Twenty-nine consecutive heart-transplant recipients prospectively received intravascular ultrasound (IVUS) of the left-anterior descending artery 1 and 12 months after transplant, with volumetric reconstruction of the proximal 30 mm. Results. Overall, patients exhibited intimal volume increase (+83%, P <0.001), wheras vessel volume remained largely unchanged (+4%, P =0.270); consequently, overall lumen volume decreased (−6%, P =0.058). Among the clinical and laboratory variables, cytomegalovirus (CMV) infection requiring treatment (occurring in 12 patients), as assessed by pp65 antigenemia, was independently associated with the impaired ability of the vessel wall to enlarge in response to intimal volume increase, ultimately resulting in lumen loss (OR [95% CI]=0.098 [0.010–0.920];P =0.042). However, adequate vessel response to intimal hyperplasia with consequent lumen preservation was observed in the remaining 17 patients who did not present CMV infection requiring treatment. Conclusions. The present study demonstrates that either adequate or inadequate coronary remodeling may occur during the first year after transplantation. Moreover, for the first time, it strongly suggests that remodeling modalities may be negatively influenced by the occurrence of clinically relevant CMV infection. Randomized prospective trials are warranted to investigate whether aggressive treatment of CMV infection may help prevent TxCAD.

Preprocedural Levels of C-Reactive Protein and Leukocyte Counts Predict 9-Month Mortality After Coronary Angioplasty for the Treatment of Unprotected Left Main Coronary Artery Stenosis

Background— An accurate preprocedural risk stratification scheme for patients with unprotected left main coronary artery (ULMCA) stenosis who are undergoing coronary stenting is lacking. We examined the predictive value of preprocedural levels of C-reactive protein (CRP), fibrinogen, and leukocyte counts with respect to 9-month clinical outcomes after stenting of the ULMCA stenosis. Methods and Results— Levels of CRP, fibrinogen, and leukocyte count were prospectively measured in 83 patients undergoing stenting of the ULMCA. A drug-eluting stent was used in 42 patients, and a bare metal stent was used in 41. The end point of the study was death and the combination of death and myocardial infarction (MI). By the 9-month follow-up, there were 11 deaths (13%), 7 MIs (8%), and 16 target lesion revascularizations (19%). Death and death/MI occurred in 19% and 31%, respectively, of 59 patients with high serum levels of CRP (>3 mg/L) but in none of 24 patients with normal CRP levels (for death, P=0.02; for death/MI, P=0.006). In multivariate analysis, the highest tertiles of CRP level (P=0.028) and leukocyte count (P=0.002) were the only independent predictors of death. The highest tertiles of CRP level (P=0.002) and leukocyte count (P=0.002) and acute coronary syndromes (P=0.05) were the only independent predictors of the combined end point death/MI. Conclusions— Elevated preprocedural levels of CRP indicate an increased risk of death and death/MI after ULMCA stenting. Inflammatory risk assessment in patients with ULMCA stenosis may be useful for selecting patients for percutaneous coronary interventions with very low risk.

The role of percutaneous balloon aortic valvuloplasty as a bridge for transcatheter aortic valve implantation.

AIMS Many inoperable patients with severe aortic stenosis (AS) are not immediately eligible for transcatheter aortic valve implantation (TAVI). We evaluated the role of percutaneous balloon aortic valvuloplasty (BAV) in this setting. METHODS AND RESULTS Among 210 consecutive patients referred to our institution for BAV, we identified three groups: immediately eligible for TAVI (n=65, 31%), excluded from TAVI (n=67, 32%), BAV as a bridge to TAVI (n=78, 37%). This last group comprised patients with low left ventricular ejection fraction, frailty or enfeebled status, symptoms of uncertain origin, critical conditions, moderate-to-severe mitral valve regurgitation, need of major non-cardiac surgery. Outpatient clinic visit and echocardiography were performed around one month after BAV to decide the final therapeutic strategy. Mean age was 81±8 years and the vast majority of patients had comorbidities and high-risk features. The incidence of periprocedural adverse events was 6.4%: 5.1% death (four patients: one procedural complication, three, natural disease progression), 1.3% minor stroke. After BAV, 46% of these patients were deemed eligible for TAVI, and 28% for cardiac surgery. Patients who underwent TAVI after bridge BAV showed 94% 30-day survival. CONCLUSIONS BAV is a safe and effective tool to bridge selected patients to TAVI when indications are not obvious.

Long-term effectiveness of early administration of glycoprotein IIb/IIIa agents to real-world patients undergoing primary percutaneous interventions: results of a registry study in an ST-elevation myocardial infarction network

AIMS To evaluate the clinical impact of early administration of glycoprotein IIb/IIIa agents (IIb/IIIa agents) in the context of a dedicated hub and spoke network allowing very prompt pharmacological/mechanical interventions. METHODS AND RESULTS Using a prospective database, we conducted a cohort study of ST-elevation myocardial infarction (STEMI) patients (n = 1124) undergoing primary percutaneous coronary interventions (PPCIs) and IIb/IIIa agents administration (period, 2003-2006). Comparisons were planned between patients receiving early IIb/IIIa agents administration (in hub/spoke centre emergency departments or during ambulance transfer; early group, n = 380) or delayed administration (in the catheterization laboratory; late group, n = 744). The primary outcome measure was long-term overall mortality/re-infarction. Baseline characteristics of the two groups were largely comparable. Angiographically, early group patients more often achieved pre-PPCI TIMI Grade 2-3 and TIMI Grade 3 flow. Clinically, the early administration group experienced lower 2-year risk of unadjusted mortality/re-infarction (17 vs. 23%; P = 0.01). After adjustment for potential confounders, early administration was associated with favourable outcome in the overall population (HR = 0.71, P = 0.03) and in high-risk subgroups (TIMI risk index >25, HR = 0.64, P = 0.02; Killip class >1, HR = 0.54, P = 0.01). CONCLUSION In patients treated by PPCI within a STEMI network setting, early administration of IIb/IIIa agents may provide long-term clinical benefits. Notably, these results appeared magnified in high-risk patients.

Optimisation of therapeutic strategies for ST-segment elevation acute myocardial infarction: the impact of a territorial network on reperfusion therapy and mortality

Objective: To assess the clinical impact of a regional network for the treatment of ST-segment elevation myocardial infarction (STEMI). Methods: All patients with STEMI (n = 1823) admitted to any of the hospitals of an area with one million inhabitants during the year 2002 (n = 858)—that is, before the network was implemented, and in 2004 (n = 965), the year of full implementation of the network, were enrolled in this study. The primary evaluation was in-hospital mortality. Secondary outcomes included the incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as death, myocardial infarction, stroke and coronary revascularisation procedures over 1-year follow-up. Results: Between 2002 and 2004, there was a major change in reperfusion strategy: primary angioplasty increased from 20.2% to 65.6% (p<0.001), fibrinolytic therapy decreased from 38.2% to 10.7% (p<0.001) and the rate of patients not undergoing reperfusion was reduced from 41.6% to 23.7% (p<0.001). In-hospital mortality decreased from 17.0% to 12.3% (p = 0.005), and this reduction was sustained at 1-year follow-up (23.9% in 2002 and 18.8% in 2004, p = 0.009). Similarly, the 1-year incidence of all MACCE was reduced from 39.5% in 2002 to 34.3% in 2004 (p = 0.01). Conclusions: Organisation of a territorial network for STEMI is associated with increased rates of reperfusion therapy and reduction of in-hospital and 1-year mortality.

Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial

AIMS To test the equivalence of high-dose bolus (HDB) tirofiban vs. abciximab during primary percutaneous coronary intervention (PPCI) in terms of ST-segment resolution (STR). METHODS AND RESULTS The FATA trial (Facilitated Angioplasty with Tirofiban or Abciximab) was a prospective, multicentre, open-label trial that enrolled 692 patients with ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. Patients were randomized 1:1 to receive abciximab (n = 341) or HDB tirofiban (n = 351). Primary endpoint was the rate of complete (> or =70%) STR 90 min after first balloon inflation. Thirty-day incidence of major bleedings, death, re-infarction and new revascularizations was also evaluated. Baseline characteristics of the two groups were well-balanced, with the exception of previous MI rates (tirofiban 6% vs. abciximab 2.6%, P = 0.03). The procedure was successful in 96.7% of the abciximab and in 96.6% of the tirofiban cohort (P = 0.94). Complete STR was obtained in 67.05% of the tirofiban and 70.45% of the abciximab group (Delta -3.4%, 95% confidence interval -10.35 to +3.56), which falls beyond the predefined Delta +/- 10% equivalence boundaries. Rates of secondary endpoints were similar between the two groups. CONCLUSION This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.

Results of coronary stenting for unstable versus stable angina pectoris.

Coronary artery stenting has been shown to improve the short- and long-term results of coronary angioplasty in mainly stable patients with 1-vessel disease, but it is uncertain whether its use in an unstable clinical setting may be safe and useful. To evaluate the stenting efficacy in patients with unstable angina, we retrospectively examined our experience with the Palmaz-Schatz balloon expandable stent in 231 consecutive patients. Patients were divided into 2 groups on the basis of symptoms at the time of stent implantation: group U (132 patients) had unstable angina, and group S (99 patients) had stable angina. After stent insertion, patients were treated with anticoagulant or combined antiplatelet therapy. Baseline characteristics of the 2 groups were comparable with the exception of age (higher in the unstable group) and angiographic characteristics of the target lesions (more unfavorable in unstable patients). In both groups, coronary stenting presented a high procedural success rate. Major in-hospital complications occurred in 9 unstable (6.8%) and in 2 stable (2%) patients (p = NS) and were mainly related to subacute stent thrombosis. In both groups, subacute stent thrombosis mostly occurred in patients treated with anticoagulant therapy (7 of 9 unstable patients, 2 of 2 stable patients). At 6-month follow-up, unstable and stable patients had a similar incidence of death (0%), Q-wave myocardial infarction (0%), and need of coronary artery bypass graft (3.2% vs 4%, p = NS), but coronary angioplasty repetition (4.8% vs 14%, p = 0.027) and target vessel revascularization (6.3% vs 17%, p = 0.019) rates were lower in the unstable group. In conclusion, stent insertion increases the short- and midterm coronary angioplasty effectiveness in unstable angina, making it possible to achieve outcomes quite comparable to stable angina. Compared with conventional anticoagulant regimen, combined antiplatelet therapy after placement of coronary stents seems to reduce the incidence of subacute thrombosis also in this clinical setting.

Emerging indications, in-hospital and long-term outcome of balloon aortic valvuloplasty in the transcatheter aortic valve implantation era.

AIMS The introduction of transcatheter aortic valve implantation (TAVI) has generated a renewed interest in the treatment of high-risk patients with severe aortic stenosis. This study describes the indications and long-term outcome of balloon aortic valvuloplasty (BAV) in recent years. METHODS AND RESULTS Between 2000 and 2010, 415 consecutive patients at our institution underwent BAV. The number of BAV per year increased sharply after the introduction of TAVI. Patients were 77.5±10.9 years old and showed important comorbidities (average logistic EuroSCORE=23.9±15.3%). We identified four cohorts according to the indications: 1) bridge for TAVI (B-TAVI; n=162); 2) bridge for aortic valve replacement (B-AVR, n=97); 3) cardiogenic shock (n=23); 4) palliation (n=133). Baseline characteristics were significantly different among groups. In-hospital mortality was 5.1%, and occurred predominantly in patients who underwent BAV in the setting of cardiogenic shock (56.5% vs. around 2% in the other subgroups). Other major events were stroke (0.5%), major vascular complications (2.2%), and life-threatening bleedings (1.5%). The cumulative one-year and two-year mortality rates were 33.2% and 57.4%, respectively, with the highest incidence in the shock group (70.7% and 80.4%) and the lowest in the B-AVR group (21.7% and 38.4%). Rehospitalisation for heart failure was 26.3% at one-year and 47.2% at two-year follow-up. CONCLUSIONS The number of BAV is increasing, mainly due to increased referral of high-risk patients and to the emerging indication of bridge for TAVI. In this complex population, BAV is relatively safe but two-year survival remains poor, and more effective and definitive treatments should be pursued in a timely fashion.

Short- and Long-Term Prognostic Significance of ST-Segment Elevation in Lead aVR in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome

We sought to evaluate the prognostic significance of ST-segment elevation (STE) in lead aVR in unselected patients with non-STE acute coronary syndrome (NSTE-ACS). We enrolled 1,042 consecutive patients with NSTE-ACS. Patients were divided into 5 groups according to the following electrocardiographic (ECG) patterns on admission: (1) normal electrocardiogram or no significant ST-T changes, (2) inverted T waves, (3) isolated ST deviation (ST depression [STD] without STE in lead aVR or transient STE), (4) STD plus STE in lead aVR, and (5) ECG confounders (pacing, right or left bundle branch block). The main angiographic end point was left main coronary artery (LM) disease as the culprit artery. Clinical end points were in-hospital and 1-year cardiovascular death defined as the composite of cardiac death, fatal stroke, and fatal bleeding. Prevalence of STD plus STE in lead aVR was 13.4%. Rates of culprit LM disease and in-hospital cardiovascular death were 8.1% and 3.8%, respectively. On multivariable analysis, patients with STD plus STE in lead aVR (group 4) showed an increased risk of culprit LM disease (odds ratio 4.72, 95% confidence interval [CI] 2.31 to 9.64, p <0.001) and in-hospital cardiovascular mortality (odds ratio 5.58, 95% CI 2.35 to 13.24, p <0.001) compared to patients without any ST deviation (pooled groups 1, 2, and 5), whereas patients with isolated ST deviation (group 3) did not. At 1-year follow-up 127 patients (12.2%) died from cardiovascular causes. On multivariable analysis, STD plus STE in lead aVR was a stronger independent predictor of cardiovascular death (hazard ratio 2.29, 95% CI 1.44 to 3.64, p <0.001) than isolated ST deviation (hazard ratio 1.52, 95% CI 0.98 to 2.36, p = 0.06). In conclusion, STD plus STE in lead aVR is associated with high-risk coronary lesions and predicts in-hospital and 1-year cardiovascular deaths in patients with NSTE-ACS. Therefore, this promptly available ECG pattern could be useful to improve risk stratification and management of patients with NSTE-ACS.