John T. Schindler

Practical Implementation of the Coronary Revascularization Heart Team

Multidisciplinary decision making has been shown to be highly effective in various aspects of medicine, most notably with the concept of tumor boards and transplant committees.1 ,2 The most updated guidelines for percutaneous coronary intervention (PCI), published jointly by the American College of Cardiology Foundation, American Heart Association, and the Society for Cardiovascular Angiography and Interventions, assign a class IC recommendation for the use of a collaborative Heart Team approach in the treatment of patients with complex coronary artery disease (CAD).3 The guidelines assert that this recommendation is based on retrospective analyses showing that patients with complex CAD referred for revascularization based on a Heart Team consensus have improved mortality compared with patients merely assigned to a particular strategy in the context of their trial enrollment. Despite the suggestion of improved mortality in this retrospective comparison, the Heart Team approach has not been adopted widely in the current clinical practice of cardiovascular medicine. This multidisciplinary innovation remains in its infancy, and numerous questions remain about its practicality, feasibility, and efficacy. For several reasons, there remains significant variability in the care delivered to patients with complex CAD.4 Numerous reports show that although differences in patient characteristics may explain some of the variability in revascularization decisions, much of this variance is physician driven, such as practicing in a fee-for-service model or high-risk anatomy for low-volume operators.4,5 As emphasis grows on informed decision making and patient-centered care, a critical evaluation of these difficult questions will be essential to discovering whether there is a clinically meaningful effect of the Heart Team approach on patients with complex CAD. Although the longstanding use of tumor boards in the field of oncology represents a functioning model of interdisciplinary care on which the Heart Team may be based, it is critical …

Paclitaxel-Eluting Versus Sirolimus-Eluting Stents in Diabetes MellitusCLINICAL PERSPECTIVE

Background—Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Methods and Results—Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES (n=677) and PES (n=328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P=0.20), death and myocardial infarction (14.9% versus 13.6%, P=0.55), repeat revascularization (14.8% versus 17.8%, P=0.36), and stent thrombosis (1.3% versus 1.3%, P=0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. Conclusions—PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.Background— Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Methods and Results— Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES ( n =677) and PES ( n =328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P =0.20), death and myocardial infarction (14.9% versus 13.6%, P =0.55), repeat revascularization (14.8% versus 17.8%, P =0.36), and stent thrombosis (1.3% versus 1.3%, P =0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. Conclusions— PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice. Received June 9, 2009; accepted October 22, 2009. # CLINICAL PERSPECTIVE {#article-title-2}

Paclitaxel-Eluting Versus Sirolimus-Eluting Stents in Diabetes Mellitus A Report From the National Heart, Lung, and Blood Institute Dynamic Registry

Background—Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Methods and Results—Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES (n=677) and PES (n=328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P=0.20), death and myocardial infarction (14.9% versus 13.6%, P=0.55), repeat revascularization (14.8% versus 17.8%, P=0.36), and stent thrombosis (1.3% versus 1.3%, P=0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. Conclusions—PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.Background— Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Methods and Results— Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES ( n =677) and PES ( n =328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P =0.20), death and myocardial infarction (14.9% versus 13.6%, P =0.55), repeat revascularization (14.8% versus 17.8%, P =0.36), and stent thrombosis (1.3% versus 1.3%, P =0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. Conclusions— PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice. Received June 9, 2009; accepted October 22, 2009. # CLINICAL PERSPECTIVE {#article-title-2}

Systemic Hypothermia to Prevent Radiocontrast Nephropathy (from the COOL-RCN Randomized Trial)

Radiocontrast nephropathy (RCN) develops in a substantial proportion of patients with chronic kidney disease (CKD) after invasive cardiology procedures and is strongly associated with subsequent mortality and adverse outcomes. We sought to determine whether systemic hypothermia is effective in preventing RCN in patients with CKD. Patients at risk for RCN (baseline estimated creatinine clearance 20 to 50 ml/min) undergoing cardiac catheterization with iodinated contrast ≥50 ml were randomized 1:1 to hydration (control arm) versus hydration plus establishment of systemic hypothermia (33°C to 34°C) before first contrast injection and for 3 hours after the procedure. Serum creatinine levels at baseline, 24 hours, 48 hours, and 72 to 96 hours were measured at a central core laboratory. The primary efficacy end point was development of RCN, defined as an increase in serum creatinine by ≥25% from baseline. The primary safety end point was 30-day composite rate of adverse events consisting of death, myocardial infarction, dialysis, ventricular fibrillation, venous complication requiring surgery, major bleeding requiring transfusion ≥2 U, or rehospitalization. In total 128 evaluable patients (mean creatinine clearance 36.6 ml/min) were prospectively randomized at 25 medical centers. RCN developed in 18.6% of normothermic patients and in 22.4% of hypothermic patients (odds ratio 1.27, 95% confidence interval 0.53 to 3.00, p = 0.59). The primary 30-day safety end point occurred in 37.1% versus 37.9% of normothermic and hypothermic patients, respectively (odds ratio 0.97, 95% confidence interval 0.47 to 1.98, p = 0.93). In conclusion, in patients with CKD undergoing invasive cardiology procedures, systemic hypothermia is safe but is unlikely to prevent RCN.

Outcomes of persistent pulmonary hypertension following transcatheter aortic valve replacement

Objectives To determine the prevalence and factors associated with persistent pulmonary hypertension (PH) following transcatheter aortic valve replacement (TAVR) and its relationship with long-term mortality. Methods Consecutive patients who underwent TAVR from July 2011 through January 2016 were studied. The prevalence of baseline PH (mean pulmonary artery pressure ≥25 mm Hg on right heart catheterisation) and the prevalence and the predictors of persistent≥moderate PH (pulmonary artery systolic pressure (PASP)>45 mm Hg on 1 month post-TAVR transthoracic Doppler echocardiography) were collected. Cox models quantified the effect of persistent PH on subsequent mortality while adjusting for confounders. Results Of the 407 TAVR patients, 273 (67%) had PH at baseline. Of these, 102 (25%) had persistent≥moderate PH. Mortality at 2 years in patients with no baseline PH versus those with PH improvement (follow-up PASP≤45 mm Hg) versus those with persistent≥moderate PH was 15.4%, 16.6% and 31.3%, respectively (p=0.049). After adjusting for Society of Thoracic Surgeons Predicted Risk of Mortality and baseline right ventricular function (using tricuspid annular plane systolic excursion), persistent≥moderate PH remained associated with all-cause mortality (HR=1.82, 95% CI 1.06 to 3.12, p=0.03). Baseline characteristics associated with increased likelihood of persistent≥moderate PH were ≥moderate tricuspid regurgitation, ≥moderate mitral regurgitation, atrial fibrillation/flutter, early (E) to late (A) ventricular filling velocities (E/A ratio) and left atrial volume index. Conclusions Persistency of even moderate or greater PH at 1 month post-TAVR is common and associated with higher all-cause mortality.

Delirium Following Transcatheter Aortic Valve Replacement: National Inpatient Sample Analysis

OBJECTIVE To investigate the risk factors for postoperative delirium and the impact of delirium on mortality and morbidity following transcatheter aortic valve implantation (TAVI). DESIGN Patients who underwent TAVI were identified using the International Classification of Diseases, 9th revision clinical modification codes from the National Inpatient Sample database. Statistical analysis of preoperative and perioperative risk factors was done to identify the independent risk factors for delirium after TAVI. SETTING Multi-institutional. PARTICIPANTS Patients who underwent TAVI from 2012 to 2013. INTERVENTIONS TAVI. MEASUREMENTS AND MAIN RESULTS Over the period of 2 years (2012-2013), 7,566 patients underwent TAVI. The incidence of delirium post-TAVI was 4.57% (345). Age >85 (odds ratio [OR] 1.03; 95% confidence interval [CI] 1.01-1.05; p = 0.003), electrolyte abnormalities (OR 1.83; 95% CI 1.17-2.87; p = 0.008), prior neurologic illness (OR 1.67; 95% CI 1.10-3.15; p = 0.01), and weight loss in the hospital (OR 1.77; 95% CI 1.05-2.99; p = 0.03) were independent risk factors for postoperative delirium (POD). Unilateral or bilateral carotid stenosis did not predispose to the development of delirium. POD was an independent risk factor for procedural morbidity (OR 3.29; 95% CI 2.05-5.28; p < 0.001). POD did not increase the risk of in-house mortality after TAVI. CONCLUSION Age of >85, electrolyte disturbance, pre-existing neurologic disease and weight loss were found to be independent risk factors for delirium. POD was associated significantly with morbidity. Owing to a significant increase in the morbidity, a thorough screening protocol and effective strategies to predict, prevent, and treat postoperative delirium would reduce the cost associated with TAVI.

Carotid artery disease and periprocedural stroke risk after transcatheter aortic valve implantation

Objective/Background: To examine the role of carotid stenosis (CS) and other independent risk factors of perioperative stroke, following transcatheter aortic valve implantation (TAVI). Materials and Methods: Using data from the National Inpatient Sample database for analysis, patients who underwent TAVI were identified using the International Classification of Diseases, Ninth Revision, Clinical Modification codes. Various preoperative and perioperative risk factors and their association with perioperative strokes were studied. Results: Data on 7566 patients who underwent a TAVI procedure from 2012 to 2013 were extracted. The average age of the patient population was 81.2 ± 0.32 years. The overall perioperative stroke rate in our patient cohort was 2.79%. Majority (94.6%) of the strokes were ischemic. Multivariate analysis showed the following independent risk factors for perioperative strokes after TAVI: female gender odds ratio (OR) = 2.25 (95% confidence interval [CI], 1.42–3.57), higher van Walraven score OR = 6.6 (95% CI = 3.71–11.73), bilateral CS OR = 4.46 (95% CI = 2.03–9.82), and TAVI with a cardiac procedure done under cardiopulmonary bypass OR = 2.84 (95% CI = 1.57–5.14). Conclusion: Bilateral carotid disease is a significant risk factor for perioperative strokes following TAVI. Preoperative screening with carotid Doppler to identify high-risk patients appears to be warranted. In addition, patients of female gender were found to have an increased risk for carotid disease.

Assessment of P2Y12 inhibitor usage and switching in acute coronary syndrome patients undergoing percutaneous coronary revascularization

BACKGROUND Dual antiplatelet therapy is recommended for patients with acute coronary syndrome (ACS) that undergo percutaneous coronary intervention (PCI). However, the effect of switching P2Y12 inhibitors between the loading dose and therapy after discharge is not well described. METHODS This post-hoc analysis of a prospectively collected registry included 3219 consecutive ACS patients who underwent PCI. Patients were categorized into four groups: clopidogrel at load and discharge (C-C), loading dose of clopidogrel and discharged on prasugrel/ticagrelor (C-PT), loading dose of prasugrel/ticagrelor and discharged on clopidogrel (PT-C), and prasugrel/ticagrelor at load and discharge (PT-PT). RESULTS While 77.6% of patients received the C-C treatment regimen and 13.6% received the PT-PT strategy, the strategy of P2Y12 switching was fairly common with 6.2% in the PT-C group and 2.6% in the C-PT group. While C-C was the most common treatment regimen, PT-C and PT-PT were more commonly used in STEMI patients than in NSTEMI or unstable angina patients. A significantly lower unadjusted incidence of the composite outcome (death, MI, and repeat revascularization) was appreciated in both the PT-C (1.0%) and PT-PT (2.3%) groups than the C-C group (4.0%). Propensity-score matched analysis still showed significantly reduced risk (HR=0.22, 95% CI 0.05-0.93, p=0.04) in the PT-C group vs. a matched group of C-C controls. CONCLUSIONS The strategy of utilizing a newer P2Y12 inhibitor and then switching to clopidogrel in ACS patients following PCI is used with some frequency in routine clinical practice and further studies should evaluate the safety and efficacy of such a strategy.

Surgical cut down for vascular access with conscious sedation for transcatheter aortic valve replacement: the best of both worlds?

OBJECTIVES Despite the established efficacy of transcatheter aortic valve replacement for aortic valve replacement, vascular complications remain a major cause of procedural morbidity and mortality. In this study, we evaluate the use of femoral artery cut down with conscious sedation and report outcomes and complications associated with this approach. METHODS Our study included 282 patients undergoing transcatheter aortic valve replacement with conscious sedation and surgical cut down for femoral access between 2015 and 2017. Data were prospectively recorded in the local institutional database and were retrospectively accessed. Descriptive statistics are presented, and a Kaplan-Meier time-to-event plot was used to estimate 1-year survival. RESULTS The mean age of the patients was 82.7 ± 7.31 years and consisted of 146 (52%) women. Echocardiographic data demonstrated a severe aortic stenosis with a mean area of 0.65 ± 0.16 cm2 and a mean gradient of 48.9 ± 13.3 mmHg. STS-PROM for the cohort was 7.2%, representing an intermediate risk group. Six (2.2%) patients died within 30 days after transcatheter aortic valve replacement. Major vascular complications occurred in 2 (0.7%) patients and minor vascular complications occurred in 6 (2.2%) patients in our cohort. Wound complications were observed in 2 (0.7%) patients. CONCLUSIONS We demonstrate that the use of conscious sedation and surgical cut down for femoral arterial access resulted in a major vascular complication rate of less than 1% and low in-hospital mortality rates without any significant increase in wound complications.

The delayed southern migration of a transcatheter aortic valve

Transcatheter aortic valve replacement has emerged as a favourable alternative in patients with severe symptomatic aortic stenosis who are at intermediate and/or high risk for open aortic valve replacement. While transcatheter aortic valve replacement has been shown to be a safe alternative to surgical aortic valve replacement in those populations, the procedure is not without risks. Transcatheter heart valve migration can occur, albeit rarely, in an acute, subacute and delayed fashion. This complication can have fatal consequences if not managed appropriately. We describe a patient who underwent a transcatheter aortic valve replacement and had evidence of transcatheter heart valve subacute migration into the left ventricular outflow tract.