Use of prasugrel and clinical outcomes in African-American patients treated with percutaneous coronary intervention for acute coronary syndromes.

OBJECTIVE: To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS). BACKGROUND: AA patients are at higher risk for adverse cardiovascular outcomes after PCI and may derive greater benefit from the use of potent antiplatelet therapy. METHODS: Using the multicenter PROMETHEUS observational registry of ACS patients treated with PCI, we grouped patients by self-reported AA or other races. Clinical outcomes at 90-day and 1-year included non-fatal myocardial infarction (MI), major adverse cardiac events (composite of death, MI, stroke, or unplanned revascularization) and major bleeding. RESULTS: The study population included 2,125 (11%) AA and 17,707 (89%) non-AA patients. AA patients were younger, more often female (46% vs. 30%) with a higher prevalence of diabetes mellitus, chronic kidney disease, and prior coronary intervention than non-AA patients. Although AA patients more often presented with troponin (+) ACS, prasugrel use was much less common in AA vs. non-AA (11.9% vs. 21.4%, respectively, P = 0.001). In addition, the use of prasugrel increased with the severity of presentation in non-AA but not in AA patients. Multivariable logistic regression showed AA race was an independent predictor of reduced use of prasugrel (0.42 [0.37-0.49], P < 0.0001). AA race was independently associated with a significantly higher risk of MI at 90-days and 1 year after PCI. CONCLUSIONS: Despite higher risk clinical presentation and worse 1-year ischemic outcomes, AA race was an independent predictor of lower prasugrel prescription in a contemporary population of ACS patients undergoing PCI.

Use of prasugrel vs clopidogrel and outcomes in patients with and without diabetes mellitus presenting with acute coronary syndrome undergoing percutaneous coronary intervention.

BACKGROUND: Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabetic patients presenting with acute coronary syndromes (ACS) remain unclear. METHODS: PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization. RESULTS: We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabetic patients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p < 0.001). At 1 year, the risk of bleeding was also higher in diabetics (4.9% vs. 4.1%, HR 1.19 [1.01-1.39], p = 0.035). After multivariable adjustment, use of prasugrel was associated with a lower risk of death in diabetic patients both at 90 days and 1 year. CONCLUSIONS: Use of prasugrel in diabetic patients with PCI-treated ACS was lower than in non-diabetics despite their high-risk profile and the severity of their clinical presentation. In diabetics, prasugrel was associated with a lower adjusted risk of 90-day death compared with clopidogrel.

Fractional flow reserve guided percutaneous coronary intervention results in reduced ischemic myocardium and improved outcomes.

OBJECTIVES: To determine if fractional flow reserve guided percutaneous coronary intervention (FFR-guided PCI) is associated with reduced ischemic myocardium compared with angiography-guided PCI. BACKGROUND: Although FFR-guided PCI has been shown to improve outcomes, it remains unclear if it reduces the extent of ischemic myocardium at risk compared with angiography-guided PCI. METHODS: We evaluated 380 patients (190 FFR-guided PCI cases and 190 propensity-matched controls) who underwent PCI from 2009 to 2014. Clinical, laboratory, angiographic, stress testing, and major adverse cardiac events [MACE] (all-cause mortality, recurrence of MI requiring PCI, stroke) data were collected. RESULTS: Mean age was 63 ± 11 years; the majority of patients were males (76%) and Caucasian (77%). Median duration of follow up was 3.4 [Range: 1.9, 5.0] years. Procedural complications including coronary dissection (2% vs. 0%, P = .12) and perforation (0% vs. 0%, P = 1.00) were similar between FFR-guided and angiography-guided PCI patients. FFR-guided PCI patients had lower unadjusted (14.7% vs. 23.2%, P = .04) and adjusted [OR = 0.58 (95% CI: 0.34-0.98)] risk of repeat revascularization at one year. FFR-guided PCI patients were less likely (23% vs. 32%, P = .02) to have ischemia and had lower (5.9% vs. 21.1%, P < .001) ischemic burden (moderate-severe ischemia) on post-PCI stress testing. Presence of ischemia post-PCI remained a strong predictor of MACE [OR = 2.14 (95%CI: 1.28-3.60)] with worse survival compared to those without ischemia (HR = 1.63 (95% CI: 1.06-2.51). CONCLUSION: Compared with angiography-guided PCI, FFR-guided PCI results in less repeat revascularization and a lower incidence of post PCI ischemia translating into improved survival, without an increase in complications.

Meta-Analysis of Usefulness of Anticoagulation After Transcatheter Aortic Valve Implantation.

Since the advent of bioprosthetic valves, the implications of long-term anticoagulation after valve replacement are unclear. There are very little data on outcomes of long-term anticoagulation after transcatheter aortic valve implantation (TAVI). Our aim was to conduct a systematic review of literature regarding anticoagulation after TAVI. The existing literature on anticoagulation after bioprosthetic valve replacement was thoroughly reviewed, including the most recent American College of Cardiology/American Heart Association 2017 guidelines for management of valvular disease, which is based on sparse, nonrandomized retrospective data. A systematic review of MEDLINE, EMBASE, and Cochrane CENTRAL databases was conducted to retrieve articles reporting outcomes on anticoagulation after TAVI, and 5 articles were retrieved. Pooled analysis revealed lower bleeding rates in the anticoagulated group (22% vs 35%, p = 0.006). Stroke and mortality were inconsistently reported by the studies. The data regarding outcomes of patients on anticoagulation after TAVI are sparse. Systematic collection of anticoagulation data in the existing registries and future trials should be strongly considered in patients undergoing TAVI.

Use of prasugrel vs clopidogrel and outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention in contemporary clinical practice: Results from the PROMETHEUS study.

BACKGROUND AND OBJECTIVES: We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice. METHODS: PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel. RESULTS: Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P<.0001) and bleeding (1.9% vs 2.9%, HR 0.65, 95% CI 0.51-0.83, P<.001). After propensity stratification, associations were attenuated and no longer significant for either outcome. Results remained consistent using different approaches to adjusting for potential confounders. CONCLUSIONS: In contemporary clinical practice, patients receiving prasugrel tend to have a lower-risk profile compared with those receiving clopidogrel. The lower ischemic and bleeding events associated with prasugrel use were no longer evident after accounting for these baseline differences.

Relationship of mitral valve annulus plane and circumflex-right coronary artery plane: Implications for Transcatheter Mitral Valve Implantation.

AIM: Transcatheter mitral valve implantation (TMVI) is a novel technology for patients with severe mitral valve disease but at high surgical risk. Imaging guidance during the procedure is critical for successful device deployment. Identification of the mitral annular plane (MAP) with fluoroscopy during the procedure is limited by lack of clearly defined landmarks. We hypothesized that a plane defined by left circumflex-right coronary arteries (LCX-RCA) would have a consistent relationship to MAP. METHODS AND RESULTS: We studied 25 patients with gated cardiac computed tomography. We identified the MAP and the LCX-RCA plane in mid systole and diastole. The distance between the two planes in prespecified four points (anterior, posterior, medial, and lateral) in the apical 2 and 3-chamber views. Alignment of the planes was described by cranial/caudal angulation for both planes in RAO 30° and LAO 90° (lateral) angulation. Mean age was 81 ± 9 years, 56% of patients had ≥2+ mitral regurgitation. In mid systole, the distances between the LCX-RCA plane and the MAP in the four points were < 5 mm in 92% of patients. In mid diastole, distances were < 5 mm in 100% of patients. In mid systole, the correlation between the caudal/cranial orientations of the 2 planes was 0.85 and 0.80 in the LAO 90° and RAO 30°, respectively (P = <0.001). In mid diastole, this was 0.92 and 0.92 in the LAO 90° and RAO 30°, respectively (P = <0.001). CONCLUSION: LCX-RCA plane has a close and consistent relationship to the MAP and can be useful to guide TMVI. Accurate imaging of mitral valve annular plane during TMVI procedure is challenging. MAP guided by fluoroscopy might be crucial to guide successful prosthesis deployment. A plane defined by the left circumflex- right coronary arteries in the atrioventricular grove has a consistent relationship with MAP; this can be used aided by pre-procedural MDCT to guide TMVI procedure. © 2016 Wiley Periodicals, Inc.

Two-Decade Trends in the Prevalence of Atherosclerotic Risk Factors, Coronary Plaque Morphology, and Outcomes in Adults Aged ≤45 Years Undergoing Percutaneous Coronary Intervention.

Data are limited about the prevalence trends of risk factors, lesion morphology, and clinical outcomes of coronary artery disease in patients, aged ≤45 years, undergoing percutaneous coronary intervention (PCI), between the bare-metal stent (BMS; 1994 to 2002) and drug-eluting stent (DES; 2003 to 2012) eras. From the PCI database at the Cleveland Clinic, we identified 1,640 patients aged ≤45 years and without a history of coronary artery bypass grafting who underwent PCI from 1994 to 2012. There were 883 patients in the BMS era cohort with a mean follow-up period of 13.15 years and 757 in the DES era cohort with a mean follow-up of 5.02 years. The DES era had more obese (51.8% vs 44.7%, p <0.001) and diabetes (23.0% vs 19.5%, p = 0.09) patients. DES era patients had more B2/C lesions (74.0% vs 32.5%, p <0.001), more severe preprocedural stenosis (86.1 ± 12.9 vs 72.2 ± 21.3, p <0.001), and longer lesions (15.5 ± 9.9 vs 9.6 ± 6.8, p <0.001). No difference was observed in the 30-day mortality between the DES and BMS eras. Irrespective of era, diabetics had worse long-term mortality (19.4% vs 9.3%, p <0.001) compared with nondiabetics. Obese patients had similar long-term outcomes compared with nonobese patients. In conclusion, patients aged ≤45 years, who underwent a PCI procedure in the DES era had worse risk factor profiles, including obesity, compared with patients in the BMS era. They also had more complex lesions. Procedural and long-term outcomes of these patients have not changed between the 2 eras. Young diabetic patients have worse long-term outcomes compared with nondiabetics.

Percutaneous Intervention for Myocardial Infarction After Noncardiac Surgery: Patient Characteristics and Outcomes.

BACKGROUND: Few studies have explored percutaneous coronary intervention (PCI) in perioperative myocardial infarction (PMI), even though PMI is a major cause of mortality in patients undergoing urgent/emergent noncardiac surgery. OBJECTIVES: This study sought to describe the angiographic characteristics and outcomes in patients presenting to the cardiac catheterization laboratory for myocardial infarction sustained after undergoing noncardiac surgery, with a detailed analysis of those undergoing PCI. METHODS: We included all patients presenting to the catheterization laboratory at our institution after PMI from 2003 to 2012, who had noncardiac surgery within the previous 7 days. Data from patients who underwent PCI were analyzed using both standard regression and time-to-event survival analysis. RESULTS: From 2003 to 2012, 1,093 patients with 3,832 person-years of follow-up underwent diagnostic coronary angiography, of whom 281 (40 ST-segment elevation myocardial infarction [STEMI] and 241 non-ST-segment elevation myocardial infarction [NSTEMI] cases) underwent PCI. Using Kaplan-Meier survival analysis, we found 30-day mortality was 5.2% and 1-year mortality was 15% in the overall population. In the PCI subpopulation, we estimated 30-day mortality to be 11.3%. The 30-day death rate in the STEMI cohort was 31.2% and 8.5% in the NSTEMI cohort of the PCI subpopulation. Stepwise logistic regression revealed the following factors as strong predictors of 30-day mortality after PCI: bleeding event after PCI (odds ratio [OR]: 4.33; 95% confidence limits (CL): 1.52 to 12.30), peak troponin T level (OR: 1.20; 95% CL: 1.08 to 1.34), and underlying peripheral vascular disease (OR: 4.86; 95% CL: 1.66 to 14.22). Cox proportional hazard analysis of survival data showed that increasing age (hazard ratio [HR]: 1.03; 95% CL: 1.01 to 1.04), bleeding after PCI (HR: 2.31; 95% CL: 1.61 to 3.32), renal insufficiency (HR: 2.26; 95% CL: 1.51 to 3.39]), and vascular surgery (HR: 1.48; 95% CL: 1.02 to 2.15]) were all significant predictors of long-term mortality after PCI. CONCLUSIONS: Perioperative MI has a markedly high mortality rate, despite PCI. Bleeding event, peak troponin T level, and peripheral vascular disease predict mortality within 30 days of PCI in this patient population. Similarly, older age, vascular surgery, bleeding event, and renal dysfunction strongly predict long-term mortality after PCI in the setting of PMI.

Frequency and factors associated with inappropriate for intervention cardiac catheterization laboratory activation.

BACKGROUND: Current guidelines emphasize timely coronary intervention with a door to balloon time of ≤90min for favorable survival impact after STEMI. Efforts to achieve these targets may result in unnecessary emergent angiography for inappropriate activations. OBJECTIVE: Evaluate the frequency, trend and factors which are significantly associated with inappropriate for intervention cardiac catheterization laboratory (CCL) activation. METHODS: We analyzed 1764 consecutive emergent CCL activation for possible ST segment elevation myocardial infarction (STEMI) between 7/2005 and 8/2013. Inappropriate for intervention activation was defined as negative STEMI (incorrect diagnosis: insignificant coronary lesion, not requiring any intervention) and inappropriate patients (true STEMI but poor CCL candidacy). RESULTS: Inappropriate for intervention CCL activation occurred in 317 patients (17.9%): 292 incorrect diagnosis (negative STEMI diagnosis), 25 inappropriate patients, with no difference in the frequency based on time of the day (18.6% regular hours vs. 17.6% off-hours, p=0.6). On multivariable analysis, female gender (OR 1.9 [1.2-3.0]), African American race (OR 1.9[1.3-2.7]), and prior coronary artery bypass graft surgery (OR 3.6 [2.3-5.5]) were significantly associated with incorrect diagnosis (negative STEMI diagnosis) (all p<0.005) and hyperlipidemia (OR 0.2 [0.1-0.3]), tobacco use (OR 0.2 [0.1-0.3]), and stroke/TIA (OR 0.2 [0.1-0.4]) had a significant inverse association (all p<0.001). ST Elevation with no reciprocal depression and pericarditis/myocarditis were the most common ECG finding and etiology respectively. CONCLUSION: Inappropriate for intervention CCL activation is not uncommon and should be closely monitored to maximize resource utilization. Females, African American patients with few or no risk factors and patients presenting ST elevation but no reciprocal depression constitute a population that may require attention.

Outcomes in Patients With Transcatheter Aortic Valve Replacement and Left Main Stenting: The TAVR-LM Registry.

BACKGROUND: A percutaneous approach with transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI) of the left main coronary artery (LM) is frequently used in high-risk patients with coexisting aortic stenosis and LM disease. Outcomes of TAVR plus LM PCI have not been previously reported. OBJECTIVES: The primary objective of the TAVR-LM registry is to evaluate clinical outcomes in patients undergoing TAVR plus LM PCI. METHODS: Clinical, echocardiographic, computed tomographic, and angiographic characteristics were retrospectively collected in 204 patients undergoing TAVR plus LM PCI. In total, 128 matched patient pairs were generated by performing 1:1 case-control matching between 167 patients with pre-existing LM stents undergoing TAVR and 1,188 control patients undergoing TAVR without LM revascularization. RESULTS: One-year mortality (9.4% vs. 10.2%, p = 0.83) was similar between the TAVR plus LM PCI cohort and matched controls. One-year mortality after TAVR plus LM PCI was not different in patients with unprotected compared with protected LMs (7.8% vs. 8.1%, p = 0.88), those undergoing LM PCI within 3 months compared with those with LM PCI greater than 3 months before TAVR (7.4% vs. 8.6%, p = 0.61), and those with ostial versus nonostial LM stents (10.3% vs. 15.6%, p = 0.20). Unplanned LM PCI performed because of TAVR-related coronary complication, compared with planned LM PCI performed for pre-existing LM disease, resulted in increased 30-day (15.8% vs. 3.4%, p = 0.013) and 1-year (21.1% vs. 8.0%, p = 0.071) mortality. CONCLUSIONS: Despite the anatomic proximity of the aortic annulus to the LM, TAVR plus LM PCI is safe and technically feasible, with short- and intermediate-term clinical outcomes comparable with those in patients undergoing TAVR alone. These results suggest that TAVR plus LM PCI is a reasonable option for patients who are at high risk for surgery.

Resource utilization for transfemoral transcatheter aortic valve replacement: An international comparison.

BACKGROUND: Transfemoral transcatheter aortic valve replacement (TF-TAVR) has enjoyed a rapid diffusion in the US and Europe, but the procedure is resource intensive. OBJECTIVES: We sought to identify differences in resource utilization between a US and European center to ascertain opportunities for improvement in the performance of TF-TAVR. METHODS: All patients undergoing TF-TAVR using the Edwards SAPIEN valve series at the San Raffaele Hospital (Milan, Italy) and the Cleveland Clinic Foundation (Cleveland, OH) between January 2011 and December 2012 were included. Resource utilization was defined as preprocedural imaging, intraprocedural imaging, and personnel present during the procedure. RESULTS: A total of 158 patients from Cleveland and 113 from Milan were analyzed. Median logistic EuroScore (22.1 vs. 15.5, P = 0.013) and STS-PROM (8.9 vs. 5.0%, P < 0.001) were higher in Cleveland. Thirty-day outcomes were similar. Majority of procedures in Milan were conducted without a cardiac surgeon (79%) or an imaging specialist (99%) present during the case. There was greater reliance on endotracheal intubation (94.3 vs. 3.5%), general anesthesia (GA: 94.3 vs. 4.4%), and intraprocedural TEE (93 vs. 12.4%) in Cleveland, but shorter length of stay (mean: 6.42 vs. 11.16 days). CONCLUSIONS: We characterized resources used for patients undergoing TF-TAVR in Cleveland and Milan. Important differences included less reliance on GA and TEE and streamlining of procedural personnel in Milan, and reduced length-of-stay in Cleveland. Evolution of TF-TAVR to involve fewer operators must be balanced with the need for ready access to a comprehensive group of specialists in case of emergencies. © 2015 Wiley Periodicals, Inc.

Renin-Angiotensin System Antagonists in Patients Without Left Ventricular Dysfunction After Percutaneous Intervention for ST-Segment Elevation Myocardial Infarction.

There is a paucity of evidence on the impact of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) on long-term outcomes in patients with ejection fraction (EF) >40% after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). We compared long-term all-cause mortality between patients with left ventricular ejection fraction (LVEF) >40% discharged on ACEi/ARB with patients who were discharged on neither of these agents. Patients discharged after percutaneous intervention for STEMI from our catheterization laboratories from January 2002 to December 2011 were considered for inclusion. Patients were excluded if they had LVEF <40% or chronic kidney disease or hypotension (systolic blood pressure <90 mm Hg any time after the procedure). Long-term mortality and discharge medications were determined using the Social Security Death Index and electronic medical record review, respectively. A total of 988 patients were included. The median follow-up duration was 4.6 years. Kaplan-Meier analysis showed no significant difference in long-term all-cause mortality in patients discharged on ACEi/ARB compared with those who were not discharged on these medications. The number needed to treat to prevent 1 death at 1 year was 714. In addition, multivariable Cox proportional hazard modeling failed to demonstrate any beneficial effect of ACEi/ARB similar to Kaplan-Meir analysis (hazard ratio 0.88, 95% confidence interval 0.57 to 1.36). In conclusion, we found no significant benefit in long-term mortality using ACEi/ARB in patients with LVEF >40% after primary percutaneous coronary intervention for STEMI.

Comparison of acute elastic recoil between the SAPIEN-XT and SAPIEN valves in transfemoral-transcatheter aortic valve replacement.

BACKGROUND: The SAPIEN-XT is a newer generation balloon-expandable valve created of cobalt chromium frame, as opposed to the stainless steel frame used in the older generation SAPIEN valve. We sought to determine if there was difference in acute recoil between the two valves. METHODS: All patients who underwent transfemoral-transcatheter aortic valve replacement using the SAPIEN-XT valve at the Cleveland Clinic were included. Recoil was measured using biplane cine-angiographic image analysis of valve deployment. Acute recoil was defined as [(valve diameter at maximal balloon inflation) - (valve diameter after deflation)]/valve diameter at maximal balloon inflation (reported as percentage). Patients undergoing SAPIEN valve implantation were used as the comparison group. RESULTS: Among the 23 mm valves, the mean (standard deviation-SD) acute recoil was 2.77% (1.14) for the SAPIEN valve as compared to 3.75% (1.52) for the SAPIEN XT valve (P = 0.04). Among the 26 mm valves, the mean (SD) acute recoil was 2.85% (1.4) for the SAPIEN valve as compared to 4.32% (1.63) for the SAPIEN XT valve (P = 0.01). Multivariable linear regression analysis demonstrated significantly greater adjusted recoil in the SAPIEN XT valves as compared to the SAPIEN valves by 1.43% [(95% CI: 0.69-2.17), P < 0.001]. However, the residual peak gradient was less for SAPIEN XT compared to SAPIEN valves [18.86 mm Hg versus 23.53 mm Hg (P = 0.01)]. Additionally, no difference in paravalvular leak was noted between the two valve types (P = 0.78). CONCLUSIONS: The SAPIEN XT valves had significantly greater acute recoil after deployment compared to the SAPIEN valves. Implications of this difference in acute recoil on valve performance need to be investigated in future studies.

Risk of cerebrovascular events in patients with patent foramen ovale and intracardiac devices.

OBJECTIVES: This study investigated whether patients with patent foramen ovale (PFO) have an increased risk of stroke due to permanent pacemaker (PPM)/implantable cardioverter-defibrillator (ICD) implantation. BACKGROUND: Data are lacking on the risk of stroke in patients with PFO and implantable intracardiac devices, either a PPM or an ICD. We investigated whether patients with PFO have increased risk of stroke due to PPM/ICD implantation. METHODS: Between 2001 and 2008, 2,921 consecutive patients with PFO (67.5 ± 16.4 years of age, 52.2% male) were identified from our echocardiography database. These patients were divided into a device group (patients had PPM/ICD implantation for any reason after receiving a diagnosis of PFO) and a no device group (patients did not have PPM or ICD implantation). Patients who had PFO closure during follow-up were excluded. Both groups were matched for baseline characteristics and medications. The incidence of ischemic stroke was assessed in each group after propensity score matching (case:control ratio of 1:1 yielding 231 pairs). All patients completed at least 4 years of follow-up until May 2012. RESULTS: There were 2,690 patients in the n device group (67.3 ± 16.4 years of age, 51.6% male) and 231 patients in the device group (75.4 ± 14.6 years of age, 59.3% male). Six patients (2.6%) in the no device group and 6 (2.6%) in the device group had a stroke during the follow-up period. No difference in the rate of stroke, transient ischemic stroke, or stroke/transient ischemic stroke was observed between the 2 groups. CONCLUSIONS: The risk of stroke in patients with PFO and an implantable intracardiac device is similar to those without an intracardiac device. In patients with PFO, without a history of stroke, device implantation might not be considered a risk factor for future stroke occurrence.

Transcatheter aortic valve replacement: experience with the transapical approach, alternate access sites, and concomitant cardiac repairs.

OBJECTIVES: Transapical transcatheter aortic valve replacement (TA-TAVR) is a viable treatment option for selected high-risk elderly patients. We analyzed the 30-day mortality and perioperative complications, focusing on the "learning curve" since our first TA procedure in 2007. We also introduce unique cases, demonstrating new possibilities for alternate access sites and concurrent cardiac interventions using the apical approach. METHODS: From February 2007 to May 2013, 150 patients underwent TA-TAVR (mean age, 81.4 ± 7 years; mean Society of Thoracic Surgeons score, 9.8±3.5). We compared 2 groups (group A, n=65, procedures from February 2007 to December 2010; group B, n=85, procedures from January 2011 to May 2013). RESULTS: Five deaths (3.3%) occurred within 30 days, with a decrease in 30-day mortality between the 2 groups (group A, n=4, 6.2%; group B, n=1, 1.2%) that became significant at 1 year (log-rank, P=.002). Severe bleeding from the apex (group A, 4.6%; group B 4.4%) and deployment of >1 valve (group A, 7.6%; group B, 10.5%) was similar in both groups. Valve embolization was less frequent in group B (group A, 4.6%; group B, 2.4%). Postoperative complications in groups A and B included stroke (3.1% vs 0%), renal failure (9.3% vs 4.7%), and permanent pacemaker implantation (6.1% vs 5.9%). No myocardial infarctions occurred in either group. Two patients received simultaneous aortic and mitral valve implantation; 1 patient undergoing TA-TAVR also underwent distal arch and descending aorta repair; all had favorable outcomes. With a further 25 TA-TAVR since May 2013, the overall mortality is 2.9% (5/175). CONCLUSIONS: Although working with the fragile apical tissues in high-risk elderly patients remains a challenge, we have demonstrated a reduction in mortality and complications with increasing experience in TA-TAVR. We have successfully demonstrated novel combined procedures and uses for the transapical approach and alternate access sites, which should continue to be explored.

Percutaneous left atrial appendage occlusion for stroke prophylaxis in nonvalvular atrial fibrillation: a systematic review and analysis of observational studies.

OBJECTIVES: The goal of this study was to provide a systematic review and analysis of observational studies on percutaneous left atrial appendage (LAA) occlusion for stroke prophylaxis in nonvalvular atrial fibrillation (NVAF). BACKGROUND: A recent randomized controlled trial in patients with NVAF suggested noninferiority of percutaneous LAA occlusion versus medical management for stroke prevention. However, the use of percutaneous devices remains controversial because of limited literature on their efficacy and safety. We performed a systematic analytical review of existing observational studies to assess the rate of neurological events for patients treated with occlusion devices. METHODS: A comprehensive search of the Medline, Scopus, and Web of Science databases from inception through August 1, 2013, was conducted using pre-defined criteria. We included studies reporting implantation in at least 10 patients and a follow-up of 6 months or more. RESULTS: In 17 eligible studies, a total of 1,052 devices were implanted in 1,107 patients with 1,586.4 person-years (PY) of follow-up. The adjusted incidence rate of stroke was 0.7/100 PY (95% confidence interval [CI]: 0.3 to 1.1/100 PY), of transient ischemic attacks was 0.5/100 PY (95% CI: 0.1 to 1.8/100 PY), and of combined neurological events (strokes or transient ischemic attacks) was 1.1/100 PY (95% CI: 0.6 to 1.6/100 PY). Access site vascular complications and pericardial effusion were the most commonly observed procedural complications at a rate of 8.6% (95% CI: 6.3% to 11.7%) and 4.3% (95% CI: 3.1% to 5.9%), respectively. CONCLUSIONS: Our systematic review suggested comparable efficacy of LAA occlusion devices compared with historical controls treated with adjusted-dose warfarin and other anticoagulation strategies for prevention of stroke in patients with NVAF.

Predicting vascular complications during transfemoral transcatheter aortic valve replacement using computed tomography: a novel area-based index.

BACKGROUND: Computed tomography (CT) imaging has not been systematically studied for predicting vascular complications during transcatheter aortic valve replacement (TAVR). METHODS: Clinical data were obtained from the electronic medical record and analysis was performed for each individual patient's iliofemoral CT angiogram. Sheath : femoral artery diameter ratio (SFAR) and sheath : femoral artery area ratio (SFAAR) were defined as the ratio of the sheath outer diameter to the femoral minimal lumen diameter (MLD) and sheath area to the femoral minimal lumen area (MLA), respectively. RESULTS: A total of 255 patients underwent TF-TAVR with a 30-day mortality of 0.4% and 30-day stroke rate of 1.6%. Twenty-eight (11%) patients suffered a vascular complication, the majority of whom (82%) were managed percutaneously. Receiver operating characteristic (ROC) curve analysis demonstrated an SFAAR of 1.35 to predict the occurrence of vascular complications with a sensitivity of 78.6%. By comparison, similar analysis using SFAR provided a value of 1.45 with sensitivity of 64.2%. Multivariable modeling confirmed SFAR [OR (95% CI): 8.3(1.8-39.1)] and log-transformed SFAAR [OR (95% CI): 40.1 (2.4-650.0)] as significant predictors of vascular complication. CONCLUSIONS: Using CT analysis, an SFAR of 1.45 and an SFAAR of 1.35 are each significant predictors of vascular complications among patients undergoing TF-TAVR. Utilization of CT-based area may provide a more accurate screen for patients undergoing evaluation for TF-TAVR as it takes into consideration the elliptical nature of the vessel. © 2014 Wiley Periodicals, Inc.

Single center TAVR experience with a focus on the prevention and management of catastrophic complications.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an important treatment option for patients with severe symptomatic aortic stenosis (AS) who are inoperable or at high risk for complications with surgical aortic valve replacement. We report here our single-center data on consecutive patients undergoing transfemoral (TF) TAVR since the inception of our program, with a special focus on minimizing and managing complications. METHODS: The patient population consists of all consecutive patients who underwent an attempted TF-TAVR at our institution, beginning with the first proctored case in May 2006, through December 2012. Clinical, procedural, and echocardiographic data were collected by chart review and echo database query. All events are reported according to Valve Academic Research Consortium-2. RESULTS: During the study period, 255 patients with AS had attempted TF-TAVR. The procedure was successful in 244 (95.7%) patients. Serious complications including aortic annular rupture (n = 2), coronary occlusion (n = 2), iliac artery rupture (n = 1), and ventricular embolization (n = 1) were successfully managed. Death and stroke rate at 30 days was 0.4% and 1.6%, respectively. One-year follow-up was complete in 171 (76%) patients. One-year mortality was 17.5% with a 3.5% stroke rate. Descending aortic rupture, while advancing the valve, was the only fatal procedural event. There were 24.4% patients with ≥2+ aortic regurgitation. CONCLUSIONS: TAVR can be accomplished with excellent safety in a tertiary center with a well-developed infrastructure for the management of serious complications. The data presented here provide support for TAVR as an important treatment option, and results from randomized trials of patients with lower surgical risk are eagerly awaited.

Impact of severe mitral regurgitation on postoperative outcomes after noncardiac surgery.

OBJECTIVE: Preoperative cardiac risk assessment scoring systems traditionally do not include valvular regurgitation as a criterion for adverse outcome prediction. We sought to determine the impact of significant mitral regurgitation on postoperative outcomes after planned noncardiac surgeries. METHODS: Patients with significant mitral regurgitation (moderate-severe or severe) undergoing noncardiac surgery were identified using surgical and echocardiographic databases at the Cleveland Clinic. The mechanism of mitral regurgitation was identified and classified as ischemic or nonischemic. By using propensity score analysis, we obtained 4 matched controls (patients undergoing noncardiac surgery without mitral regurgitation) for each case. The primary outcome was defined as a composite of 30-day mortality, myocardial infarction, heart failure, and stroke. Secondary outcomes included 30-day mortality, myocardial infarction, heart failure, stroke, and atrial fibrillation. RESULTS: A total of 298 cases and 1172 controls were included in the study. The incidence of primary outcome was significantly higher among patients with mitral regurgitation (22.2%) compared with controls (16.4%, P=.02). Analysis of the secondary outcomes revealed significant differences in perioperative heart failure (odds ratio, 1.4; 95% confidence interval, 1.02-2.0) and perioperative myocardial infarction (odds ratio, 2.9; 95% confidence interval, 1.2-7.3). Of patients with mitral regurgitation, those with ischemic mitral regurgitation had significantly more events than those with nonischemic mitral regurgitation (39.2% vs 13.3%, P<.001). CONCLUSIONS: Patients undergoing noncardiac surgery with significant ischemic mitral regurgitation are at higher risk of a composite adverse postoperative outcome, including short-term mortality, heart failure, myocardial infarction, and stroke.