Fabio Sandoli de Brito

Late Cardiac Death in Patients Undergoing Transcatheter Aortic Valve Replacement Incidence and Predictors of Advanced Heart Failure and Sudden Cardiac Death

BACKGROUNDnLittle evidence exists of the burden and predictors of cardiac death after transcatheter aortic valve replacement (TAVR).nnnOBJECTIVESnThe purpose of this study was to assess the incidence and predictors of cardiac death from advanced heart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR.nnnMETHODSnThe study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable (43%) valves. Causes of death were defined according to the Valve Academic Research Consortium-2.nnnRESULTSnAt a mean follow-up of 22 ± 18 months, 155 patients had died due to advanced HF (15.2% of total deaths, 46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baseline comorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction ≤40%, lower mean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p < 0.05 for all) and 2 procedural factors (transapical approach, hazard ratio [HR]: 2.38, 95% confidence interval [CI]: 1.60 to 3.54; p < 0.001; presence of moderate or severe aortic regurgitation after TAVR, HR: 2.79, 95% CI: 1.82 to 4.27; p < 0.001) independently predicted death from advanced HF. Left ventricular ejection fraction ≤40% (HR: 1.93, 95% CI: 1.05 to 3.55; p = 0.033) and new-onset persistent left bundle-branch block following TAVR (HR: 2.26, 95% CI: 1.23 to 4.14; p = 0.009) were independently associated with an increased risk of SCD. Patients with new-onset persistent left bundle-branch block and a QRS duration >160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p = 0.006).nnnCONCLUSIONSnAdvanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR. Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future studies should determine whether targeting these factors decreases the risk of cardiac death.

Comparison of direct stenting versus stenting with predilation for the treatment of selected coronary narrowings.

Direct stenting may reduce costs, procedure times, and injury to the vessel wall, positively influencing acute and late results. This study was designed to demonstrate 6-month clinical outcome equivalence between direct and standard stenting techniques. Four hundred eleven patients (425 lesions) were randomized in 7 sites to undergo direct (210 patients, 216 lesions) or conventional (201 patients, 209 lesions) stent implantation. Lesions with severe calcification were excluded. Angiographic success rate was 100% in the direct stent group (2.8% requiring balloon predilation) and 98.6% in the predilation group (p = 0.12). Direct stenting was associated with decreased use of balloons (0.15 vs 1.09 balloons/lesion treated) and with a trend toward a reduction of procedure time (22.7 +/- 15.0 vs 25.6 +/- 18.2 minutes; p = 0.073). Fluoroscopy time and contrast volume were not different between groups. At 6-month follow-up, the incidences of death (direct [1.4%] vs predilation [2.5%]), myocardial infarction (5.3% vs 5.0%), and target vessel revascularization (8.2% vs 10.5%) were similar in both groups. Major adverse cardiac event-free survival rate was 87.5% for those who underwent the direct stent technique and 85.5% for patients who underwent predilation (p = 0.0002 for equivalence). In conclusion, direct stenting is at least equivalent to the standard technique in terms of 6-month clinical outcomes when performed on selected coronary lesions without significant calcification. This strategy is associated with decreased use of balloons, but, in general, does not significantly reduce procedure times.

The impact of calcium volume and distribution in aortic root injury related to balloon-expandable transcatheter aortic valve replacement

BACKGROUNDnA detailed assessment of calcium within the aortic root may provide important additional information regarding the risk of aortic root injury during transcatheter heart valve replacement (TAVR).nnnOBJECTIVEnWe sought to delineate the effect of calcium volume and distribution on aortic root injury during TAVR.nnnMETHODSnThirty-three patients experiencing aortic root injury during TAVR with a balloon-expandable valve were compared with a control group of 153 consecutive TAVR patients without aortic root injury (as assessed by post-TAVR multidetector CT). Using commercial software to analyze contrast-enhanced pre-TAVR CT scans, calcium volume was determined in 3 regions: (1) the overall left ventricular outflow tract (LVOT), extending 10xa0mm down from the aortic annulus plane; (2) the upper LVOT, extending 2xa0mm down from the annulus plane; and (3) the aortic valve region.nnnRESULTSnCalcium volumes in the upper LVOT (median, 29 vs 0xa0mm(3); P < .0001) and overall LVOT (median, 74 vs 3xa0mm(3); Pxa0= .0001) were higher in patients who experienced aortic root injury compared with the control group. Calcium in the aortic valve region did not differ between groups. Upper LVOT calcium volume was more predictive of aortic root injury than overall LVOT calcium volume (area under receiver operating curve [AUC], 0.78; 95% confidence interval, 0.69-0.86 vs AUC, 0.71; 95% confidence interval, 0.62-0.82; Pxa0= .010). Upper LVOT calcium below the noncoronary cusp was significantly more predictive of aortic root injury compared to calcium underneath the right coronary cusp or the left coronary cusp (AUC, 0.81 vs 0.68 vs 0.64). Prosthesis oversizing >20% (likelihood ratio test, Pxa0= .028) and redilatation (likelihood ratio test, Pxa0= .015) improved prediction of aortic root injury by upper LVOT calcium volume.nnnCONCLUSIONnCalcification of the LVOT, especially in the upper LVOT, located below the noncoronary cusp and extending from the annular region, is predictive of aortic root injury during TAVR with a balloon-expandable valve.

Coronary Obstruction Following Transcatheter Aortic Valve Implantation

Background Transcatheter aortic valve implantation (TAVI) was established as an important alternative for high-risk patients with severe aortic stenosis. However, there are few data in the literature regarding coronary obstruction, that although rare, is a potentially fatal complication. Objective Evaluate this complication in Brazil. Methods We evaluated all patients presenting coronary obstruction from the Brazilian Registry of TAVI. Main baseline and procedural characteristics, management of the complication, and clinical outcomes were collected from all patients. Results From 418 consecutive TAVI procedures, coronary obstruction occurred in 3 cases (incidence of 0.72%). All patients were women, without prior coronary artery bypass grafting (CABG), and with mean age of 85 ± 3 years, logistic EuroSCORE of 15 ± 6% and STS-PROM score of 9 ± 4%. All of the cases were performed with balloon-expandable Sapien XT prosthesis. In one patient, with pre-procedural computed tomography data, coronary arteries presented a low height and a narrow sinus of Valsalva. All patients presented with clinically significant severe maintained hypotension, immediately after valve implantation, and even though coronary angioplasty with stent implantation was successfully performed in all cases, patients died during hospitalization, being two periprocedurally. Conclusion Coronary obstruction following TAVI is a rare but potentially fatal complication, being more frequent in women and with the balloon-expandable prosthesis. Anatomical factors might be related with its increased occurrence, highlighting the importance of a good pre-procedural evaluation of the patients in order to avoid this severe complication.

Clinical Impact of Baseline Right Bundle Branch Block in Patients Undergoing Transcatheter Aortic Valve Replacement

OBJECTIVESnThis study sought to assess the influence of baseline right bundle branch block (RBBB) on all-cause and cardiovascular mortality as well as sudden cardiac death (SCD) among patients undergoing transcatheter aortic valve replacement (TAVR).nnnBACKGROUNDnFew data exist regarding the late clinical impact of pre-existing RBBB in TAVR recipients.nnnMETHODSnA total of 3,527 patients (mean age 82 ± 8 years, 50.1% men) were evaluated according to the presence of RBBB on baseline electrocardiography. Intraventricular conduction abnormalities were classified according to the American Heart Association, American College of Cardiology Foundation, and Heart Rhythm Society recommendations for standardization and interpretation of the electrocardiogram. TAVR complications and causes of death were defined according to Valve Academic Research Consortium 2 definitions.nnnRESULTSnRBBB was present on baseline electrocardiography in 362 patients (10.3%) and associated with higher 30-day rates of permanent pacemaker implantation (PPI) (40.1% vs. 13.5%; pxa0< 0.001) and death (10.2% vs. 6.9%; pxa0= 0.024). At a mean follow-up of 20 ± 18 months, pre-existing RBBB was independently associated with all-cause mortality (hazard ratio [HR]: 1.31; 95% confidence interval [CI]: 1.06 to 1.63; pxa0= 0.014) and cardiovascular mortality (HR: 1.45; 95% CI: 1.11 to 1.89; pxa0= 0.006) but not with SCD (HR: 0.71; 95% CI: 0.22 to 2.32; pxa0= 0.57). Patients with pre-existing RBBB and without PPI at discharge from the index hospitalization had the highest 2-year risk for cardiovascular death (27.8%; 95% CI: 20.9% to 36.1%; log-rank pxa0= 0.007). In a subanalysis of 1,245 patients without PPI at discharge from the index hospitalization and with complete follow-up regarding the need for PPI, pre-existing RBBB was independently associated with the composite of SCD and PPI (HR: 2.68; 95% CI: 1.16 to 6.17; pxa0= 0.023).nnnCONCLUSIONSnPre-existing RBBB was found in 10% of TAVR recipients and was associated with poorer clinical outcomes. Patients with baseline RBBB without permanent pacemakers at hospital discharge may be at especially highxa0risk for high-degree atrioventricular block and/or SCD during follow-up. Future studies should evaluate strategies aimed at the early detection of patients at risk for late development of high-degree atrioventricular block.

Comparação dos stents farmacológicos vs. stents convencionais para o tratamento do infarto agudo do miocárdio com supradesnivelamento do segmento ST: resultados do Registro EINSTEIN

BACKGROUND: Randomized clinical trials comparing drug-eluting stents (DES) with bare metal stents (BMS) in the setting of ST-segment elevation myocardial infarction (STEMI) have been showing conflicting results. Additionally, issues regarding stent thrombosis and the lack of long-term clinical outcomes have limited the widespread use of DES in STEMI. OBJECTIVE: To compare the rates of major adverse cardiac events (MACE) and stent thrombosis in unselected patients who underwent primary or rescue percutaneous coronary intervention with BMS implantation with those treated with DES. METHODS: Between January 2001 and July 2007, 251 consecutive patients with STEMI underwent PCI with BMS (n = 112) or DES (n =139). We investigated the incidence of MACE, including death, myocardial infarction and target vessel revascularization (TVR), as well as stent thrombosis rates. RESULTS: Overall, the mean age was 63 ± 13 years-old and 77% were male. The median clinical follow-up was 2.8 years (1.3-4.4). The cumulative incidence of MACE was higher in patients who received BMS as compared with DES (25.2% vs. 10.1%; p < 0.01) driven by a higher incidence of all-cause mortality (17.8% vs. 5.1%; p < 0.01), mainly cardiac death (15.9 vs. 4.3; p < 0.01). TVR was detected in 8 patients (7.5%) with BMS and in 5 patients (3.6%) with DES (p = 0.25). The incidence of stent thrombosis was similar between groups (3.7% vs. 2.2%; p = 0.7). CONCLUSIONS: In this observational series, the use of DES in the setting of STEMI showed lower rates of MACE compared to BMS at the long-term follow-up.

Primary Angioplasty in the ACCEPT Registry: Why has it Been Difficult to Accept and Implement the Radial Artery Access as Preferential?

Obtaining arterial access is the initial and fundamental step of coronary intervention procedures. Since its first application for coronary angiography1 and percutaneous coronary intervention2, the radial approach has been known to have important clinical benefits, associated with a reduction in vascular and bleeding complications at the puncture site, and with early ambulation and greater patients satisfaction as compared with the femoral approach. Recently, evidence from large randomized studies and meta-analyses3,4 has suggested that, for patients diagnosed with ST-segment elevation myocardial infarction (STEMI), the primary intervention via radial access is associated with a significant reduction in mortality rates and lower incidence of adverse cardiac events. Because of the consistency of those findings, international guidelines5 have recommended the radial approach for STEMI (class IIa, level of evidence B). n nIncorporation of the radial access, however, has not been widespread, differing worldwide. More than 80% of the coronary interventions in France are performed via the radial artery approach. Data from the British Cardiovascular Intervention Society - National Institute for Clinical Outcomes Research (BCIS-NICOR)6 have indicated a rapid increase in the use of that approach in recent years, from 12.5% in 2006 to 49.5% in 2010. In the United States, however, only 16% of the interventions from 2007 to 2012 have used the radial artery access7. Until recently, brazilian data were scarse. According to the Brazilian Cardiovascular Intervention Center (Cenic), from 2005 to 2008, the radial access was used in 12.6% of the cases, and no significant increase has been observed in those years8. In a welcome and recently published article, Andrade et al.9 have reported an updated overview on the subject. They used data from a large Brazilian prospective and multicenter registry designed by the Brazilian Society of Cardiology, comprising 47 public and private hospital centers, representative of all the Brazilian regions. Those authors have assessed the occurrence of ischemic and hemorrhagic adverse events in 588 patients submitted to primary angioplasty via the femoral and radial accesses in 2010 and 2011. The radial technique was used in 30.3% of the cases, but was not associated with a reduction in the occurrence of death, reinfarction or stroke. Severe bleedings were reported in only 1.1% of the patients and did not statistically differ according to the arterial access used. Although the low incidence of cardiac and hemorrhagic complications can reflect the quality of the centers selected and the experience of the interventional cardiologists with both vascular access, as suggested by the researchers, the results of that registry indicate a dissociation between the available scientific evidence, which points to the significant benefits of the radial access in STEMI, and the actual use of that technique and its results in daily practice.

Recomendações da sociedade brasileira de arritmias cardíacas para serviços de holter

Background There are innumerous indicators to assure the quality of a service. However, medical competence and the proper performance of a procedure determine its final quality. The Brazilian Society of Cardiac Arrhythmias recommends minimum parameters necessary to guarantee the excellence of ambulatory electrocardiographic monitoring services. Objective To recommend minimum medical competences and the information required to issue a Holter monitoring report. Methods This study was grounded in the concept of evidence-based medicine and, when evidence was not available, the opinion of a writing committee was used to formulate the recommendation. That committee consisted of professionals with experience on the difficulties of the method and management in providing services in that area. Results The professional responsible for the Holter monitoring analysis should know cardiovascular pathologies and have consistent formation on electrocardiography, including cardiac arrhythmias and their differential diagnoses. The report should be written in a clear and objective way. The minimum parameters that comprise a Holter report should include statistics of the exam, as well as quantification and analysis of the rhythm disorders observed during monitoring. Conclusion Ambulatory electrocardiographic monitoring should be performed by professionals knowledgeable about electrocardiographic analysis, whose report should comprise the minimum parameters mentioned in this document.

Infective Endocarditis After Transcatheter Aortic Valve ImplantationCLINICAL PERSPECTIVE

Background— We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). Methods and Results— This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1–14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55–9.64; P=0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37–7.14; P=0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure (P=0.037) and septic shock (P=0.002) were associated with increased in-hospital mortality. Conclusions— The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.Background— We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI).nnMethods and Results— This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1–14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55–9.64; P =0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37–7.14; P =0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure ( P =0.037) and septic shock ( P =0.002) were associated with increased in-hospital mortality.nnConclusions— The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.nn# CLINICAL PERSPECTIVE {#article-title-37}

Infective Endocarditis After Transcatheter Aortic Valve ImplantationCLINICAL PERSPECTIVE: Results From a Large Multicenter Registry

Background— We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). Methods and Results— This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1–14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55–9.64; P=0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37–7.14; P=0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure (P=0.037) and septic shock (P=0.002) were associated with increased in-hospital mortality. Conclusions— The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.Background— We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI).nnMethods and Results— This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1–14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55–9.64; P =0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37–7.14; P =0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure ( P =0.037) and septic shock ( P =0.002) were associated with increased in-hospital mortality.nnConclusions— The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.nn# CLINICAL PERSPECTIVE {#article-title-37}