Sa’ar Minha

Trends in Complications and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Experience From the PARTNER Continued Access Registry.

OBJECTIVESnThe aim of this study was to examine trends in the rates of complications and outcomes of patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR).nnnBACKGROUNDnIt is unknown whether an evolution of case selection or accrual of case experience over time has resulted in a change in the rates of complications and outcomes of patients undergoing TF-TAVR.nnnMETHODSnTF-TAVR patients enrolled in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial) nonrandomized continued access registry (Nxa0= 1,063, enrolled March 2011 to January 2012 after completion of the randomized trial) were divided into tertiles (T1 through T3) based on enrollment date. Patient characteristics and rates of adverse events were compared over time.nnnRESULTSnThere were no significant differences in sex, New York Heart Association functional classes III/IV, diabetes, coronary artery disease, previous revascularization, pulmonary hypertension, renal disease, or liver disease. There was an increase in mean age, but a decrease in porcelain aorta, chronic obstructive pulmonary disease (including oxygen-dependent chronic obstructive pulmonary disease), previous chest wall radiation, and a slight decrease in the median Society of Thoracic Surgeons Predicted Risk of Mortality score. There was a significant decline in the frequency of patients deemed inoperable (cohort B) and in need for post-dilation. Percutaneous access increased significantly. There were no differences in post-procedural stroke, major bleeding, major vascular complications, or the need for aortic valve reintervention over time. The incidence of moderate/severe paravalvular regurgitation declined significantly as did all-cause mortality at 1 and 2 years.nnnCONCLUSIONSnA significant reduction in the incidence of moderate/severe paravalvular regurgitation as well as longer term all-cause mortality was observed over time. The cause of these reductions was likely multifactorial, including improved case selection and procedural techniques and increased site experience. (THE PARTNER TRIAL [Placement of AoRTic TraNscathetER Valve Trial]; NCT00530894).

Overview of the 2013 Food and Drug Administration Circulatory System Devices Panel Meeting on the MitraClip Delivery System

The MitraClip system (MCS; Abbott Vascular, Santa Clara, CA) is a percutaneously delivered device aimed at reducing severe mitral valve regurgitation (MR) by approximating the mitral valve leaflets. The device is introduced through the femoral vein and advanced into the left atrium through a transseptal puncture. With echocardiographic guidance, the MitraClip is permanently placed in a fashion that approximates the anterior and posterior leaflets as seen in the surgical technique by Alfieri and De Bonis,1 although it should be noted that this technique includes mitral annuloplasty as an essential component. After being in development for more than a decade, the MCS was approved for commercial use in Europe in 20082 and is recommended by the European Society of Cardiology for use in patients with symptomatic severe MR who are determined to be inoperable or at high surgical risk by a heart team and who have a life expectancy >1 year (recommendation Class IIb , Level of Evidence C ).3 The MitraClip is currently approved for use in >40 countries with >8000 patients having been treated with this device, most of whom are at high surgical risk.2nnOn March 20, 2013, the Food and Drug Administration’s (FDA’s) Circulatory System Devices Panel met to discuss the premarket approval (PMA) application for the MCS. The scientific data presented to support the PMA were based on the pivotal randomized, controlled Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II trial,4 along with data from 2 registries: 1 derived from a subgroup analysis of the EVEREST II data and 1 derived from continued-access registries.nnThe first US MCS clinical trial, EVEREST I, was a single-arm feasibility registry of 55 patients. This trial completed its 5-year follow-up with reassuring results. The pivotal EVEREST II trial, initiated in August 2005, was a randomized, controlled …

Clinical Presentation and Outcomes of Coronary In-Stent Restenosis Across 3-Stent Generations

Background—Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients undergoing target lesion revascularization is well characterized and negatively affects on outcomes, whereas the presentation and outcomes of first- and second-generation drug-eluting stents (DESs) remains under-reported. Methods and Results—The study included 909 patients (1077 ISR lesions) distributed as follows: bare metal stent (n=388), first-generation DES (n=425), and second-generation DES (n=96), categorized into acute coronary syndrome (ACS) or non-ACS presentation mode at the time of first target lesion revascularization. ACS was further classified as myocardial infarction (MI) and unstable angina. For bare metal stent, first-generation DES and second-generation DES, ACS was the clinical presentation in 67.8%, 71.0%, and 66.7% of patients, respectively (P=0.470), whereas MI occurred in 10.6%, 10.1%, and 5.2% of patients, respectively (P=0.273). The correlates for MI as ISR presentation were current smokers (odds ratio, 3.02; 95% confidence interval [CI], 1.78–5.13; P<0.001), and chronic renal failure (odds ratio, 2.73; 95% CI, 1.60–4.70; P<0.001), with a protective trend for the second-generation DES ISR (odds ratio, 0.35; 95% CI, 0.12–1.03; P=0.060). ACS presentations had an independent effect on major adverse cardiac events (death, MI, and re-target lesion revascularization) at 6 months (MI versus non-ACS: adjusted hazard ratio, 4.06; 95% CI, 1.84–8.94; P<0.001; unstable angina versus non-ACS: adjusted hazard ratio, 1.98; 95% CI, 1.01–3.87; P=0.046). Conclusions—ISR clinical presentation is similar irrespective of stent type. MI as ISR presentation seems to be associated with patient and not device-related factors. ACS as ISR presentation has an independent effect on major adverse cardiac events, suggesting that ISR remains a hazard and should be minimized.

Rational use of rotational atherectomy in calcified lesions in the drug-eluting stent era: Review of the evidence and current practice

Percutaneous coronary interventions of calcified coronary lesions are associated with worse clinical outcomes compared with noncalcified lesions and are still considered a technical challenge for interventional cardiologists. Rotational atherectomy (RA) can effectively optimize lesion preparation through plaque modification of heavily calcified coronary lesions. However, in conventional balloon angioplasty and bare metal stent eras, the use of RA was not associated with a significant improvement in restenosis and target lesion revascularization in patients with calcified lesions. Drug-eluting stents (DES) dramatically reduced the rates of restenosis and major adverse cardiac events. In the DES era, the need for RA is therefore questionable. Recently, some studies have reported clinical outcomes of patients with calcified lesions treated with DES and RA. In this article, we aim to critically review results from these randomized and observational clinical studies assessing the use of RA in the DES era.

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety

OBJECTIVESnIntroduction of hybrid techniques, such as transapical transcatheter aortic valve replacement (TA-TAVR), requires skills that a heart team must master to achieve technical efficiency: the technical performance learning curve. To date, the learning curve for TA-TAVR remains unknown. We therefore evaluated the rate at which technical performance improved, assessed change in occurrence of adverse events in relation to technical performance, and determined whether adverse events after TA-TAVR were linked to acquiring technical performance efficiency (the learning curve).nnnMETHODSnFrom April 2007 to February 2012, 1100 patients, average age 85.0xa0±xa06.4xa0years, underwent TA-TAVR in the PARTNER-I trial. Learning curves were defined by institution-specific patient sequence number using nonlinear mixed modeling.nnnRESULTSnMean procedure time decreased from 131 to 116xa0minutes within 30 cases (Pxa0=xa0.06) and device success increased to 90% by case 45 (Pxa0=xa0.0007). Within 30xa0days, 354 patients experienced a major adverse event (stroke in 29, death in 96), with possibly decreased complications over time (Pxa0∼xa0.08). Although longer procedure time was associated with more adverse events (Pxa0<xa0.0001), these events were associated with change in patient risk profile, not the technical performance learning curve (Pxa0=xa0.8).nnnCONCLUSIONSnThe learning curve for TA-TAVR was 30 to 45 procedures performed, and technical efficiency was achieved without compromising patient safety. Although fewer patients are now undergoing TAVR via nontransfemoral access, understanding TA-TAVR learning curves and their relationship with outcomes is important as the field moves toward next-generation devices, such as those to replace the mitral valve, delivered via the left ventricular apex.

Racial disparity with on-treatment platelet reactivity in patients undergoing percutaneous coronary intervention

BACKGROUNDnOn-treatment platelet reactivity to clopidogrel is variable and in part genetic dependent. In African American (AA) patients, the relation between on-treatment platelet reactivity to clopidogrel and the factors that influence this interaction is unknown. The present study aims to evaluate on-treatment platelet reactivity to clopidogrel in AA patients and its interaction to race and CYP2C19*2 loss of function mutation.nnnMETHODSnThe study cohort included 289 consecutive patients presenting for percutaneous coronary intervention who were entered into a prospective observational registry. High on-treatment platelet reactivity (HTPR) was defined as P2Y12 reaction units (PRU) ≥208 with VerifyNow P2Y12 assay and >50% by vasodilator-stimulated phosphoprotein phosphorylation assay platelet reactivity index (VASP PRI) measured 6 to 24 hours postprocedure. CYP2C19*2 (rs4244285) genotype was analyzed by real-time polymerase chain reaction.nnnRESULTSnThe prevalence of HTPR by both PRU (56% vs 35%, P = .003) and VASP PRI (67% vs 45%, P = .002) is more common in AAs compared with whites, respectively. African American patients had higher on-treatment mean PRU (207 ± 110 vs 160 ± 102, P = .002) and VASP PRI (49 ± 26 vs 38 ± 26, P = .004). African Americans also had a higher prevalence of CYP2C19*2 allele carrier status compared with whites (43% vs 29%, P = .04). African American race (P = .008) and CYP2C19*2 allele status (P = .02) independently had significant effects on PRU and VASP. Multivariable logistic regression analysis has shown that both CYP2C19*2 allele carrier status and AA race were independent correlates of HTPR for PRU ≥208.nnnCONCLUSIONSnAfrican American patients undergoing percutaneous coronary intervention not only have a higher prevalence of HTPR to clopidogrel but also have higher CYP2C19*2 allele carrier status compared with whites. Careful selection of antiplatelet agents should be considered in an AA population at higher risk for ischemic complications.

Use of emergency medical services expedites in-hospital care processes in patients presenting with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

To determine whether door-to-balloon (DTB) times of patients presenting with ST-elevation myocardial infarction (STEMI) were reduced in patients transported by emergency medical services (EMS) compared to those who were self-transported. DTB time is an important measure of hospital care processes in STEMI. Use of EMS may expedite in-hospital processing and reduce DTB times. A total of 309 consecutive STEMI patients who underwent primary percutaneous coronary intervention in our institution were analyzed. Excluded were patients who received fibrinolytics, presented in cardiac arrest, were intubated, or were transferred from another hospital. EMS-transported patients (n=83) were compared to self-transported patients (n=226). The primary outcome measure was DTB time and its component time intervals. Secondary end points included symptom-to-door and symptom-to-balloon times, and correlates for DTB >90 minutes. A higher percentage of EMS-transported patients reached the time goal of DTB <90 minutes compared to self-transported patients (83.1 versus 54.3%; p<0.001). EMS-transported patients had shorter DTB times [median (IQR) minutes, 65 (50-86) versus 85 (61-126); p<0.001] due to a reduction of emergency department processing (door-to-call) time, whereas catheterization laboratory processing (call-to-balloon) times were similar in both groups. EMS-transported patients had shorter symptom-to-door [median (IQR) hours, 1.2 (0.8-3.5) versus 2.3 (1.2-7.5); p<0.001] and symptom-to-balloon [median (IQR) hours, 2.5 (1.9-4.7) versus 4.3 (2.6-9.1); p<0.001]. Independent correlates of DTB times >90 minutes were self-transport (odds ratio 5.32, 95% CI 2.65-10.70; p<0.001) and off-hours presentation (odds ratio 2.89, 95% CI 1.60-5.22; p<0.001). Use of EMS transport in STEMI patients significantly shortens time to reperfusion, primarily by expediting emergency department processes. Community education efforts should focus not only on the importance of recognizing symptoms of myocardial infarction, but also taking early action by calling the EMS.

Does baseline hematocrit influence the assays of on-treatment platelet reactivity to clopidogrel?

BACKGROUNDnHigh on-treatment platelet reactivity (HTPR) has been shown to be associated with adverse cardiac events in patients undergoing percutaneous coronary intervention, but the effect of baseline hematologic parameters upon platelet reactivity remains controversial.nnnOBJECTIVEnThe present study aims to evaluate the impact of hematocrit on 2 different assay methods used to assess on-treatment platelet reactivity to clopidogrel.nnnMETHODSnWe tested clopidogrel on-treatment platelet reactivity in 466 consecutive patients using VerifyNow P2Y12 (VN) and light transmission aggregometry (LTA) with adenosine diphosphate (ADP) 5 and 20 μM assays 6 to 24 hours after percutaneous coronary intervention. Patients were categorized into 4 groups according to baseline hematocrit. One-year major adverse cardiac events, including death, nonfatal myocardial infarction, and definite stent thrombosis, were collected.nnnRESULTSnLower hematocrit was associated with higher P2Y12 reaction unit (PRU) and a higher rate of HTPR (P < .001) as measured by VN assay. No differences were seen among the 4 groups in platelet reactivity measured by LTA using ADP 5 μM (P = .23) and ADP 20 μM (P = .21). In a multivariable logistic regression model, baseline hematocrit was independently associated with PRU ≥208 (odds ratio [OR] 0.92, 95% CI 0.86-0.97, P = .005) but had no correlation with LTA ADP 5 μM ≥46% (OR 1.0, 95% CI 0.95-1.06, P = .88) or LTA ADP 20 μM ≥59% (OR 1.03, 95% CI 0.97-1.09, P = .39). In a logistic regression model, the addition of VN assay results, hematocrit, and interaction between the hematocrit and assay results had shown a significant influence on the area under curve for prediction of 1-year major adverse cardiac events compared with baseline clinical variables only for PRU (0.63 vs 0.76, P = .006) but not with LTA (0.64 vs 0.74, P = .13).nnnCONCLUSIONnBaseline hematocrit has a differential influence on results of the ex vivo platelet functional assays. Lower baseline hematocrit was independently associated with HTPR by VN but not LTA. This may affect the interpretation of platelet function testing in patients with significant anemia.

Stroke After Aortic Valve Replacement The Known and Unknown

Stroke after aortic valve surgery is known as a devastating complication and is associated with increased morbidity and mortality.1 Transcatheter aortic valve replacement (TAVR) has emerged as a valid alternative for surgical aortic valve replacement (SAVR) both in inoperable patients and in those at high risk for surgery; however, the encouraging results were hampered by various complications, including stroke. In the pivotal Placement of Aortic Transcatheter (PARTNER) trial, the initial stroke rates of TAVR patients were almost double the stroke rates in patients who underwent SAVR (3.8% versus 2.1%; P =0.2),2 and this potentially affected the decision to choose 1 procedure over the other. However, continued follow-up to 3 years equated the stroke rates in SAVR and TAVR. More recent SAVR and TAVR data indicate that stroke rates in both procedural alternatives has declined, with rates of 1.7% to 2.5% from large registries such as the Society for Thoracic Surgeons and the German Aortic Valve registries.3,4 However, the unknowns with respect to stroke after AVR are numerous. In evaluations of neurological complications, overt clinical and obvious disabling stroke is only 1 potential neurological event that could occur after the procedure, and as opposed to permanent neurological deficits, these events either are clinically silent or go unnoticed because physicians are not performing tests to rule out these events (ie, cognitive deficits). The incidence and impact of these events on outcome are unknown. Furthermore, the role and impact of magnetic resonance imaging (MRI) detection of silent strokes also remain unknown.nnArticle see p 2253nnIn the current issue of Circulation , Messe and colleagues5 prospectively assessed the incidence of both clinical stroke and silent neurological events in 196 patients ≥65 years of age who underwent SAVR as recorded by serial neurological examinations and MRI. The incidence …

In-stent restenosis of drug-eluting stents

Drug-eluting stents (DES) have emerged as an improved alternative to bare-metal stents by demonstrating reduced rates of restenosis and target lesion revascularization. This emergence has led to the unrestricted use of DES for various indications and lesions, and subsequently revealed DES in-stent restenosis as a novel interventional therapeutic dilemma. Recent insights regarding the patho-physiological processes and therapeutic alternatives have added to the accumulated knowledge regarding the appropriate approach to this phenomenon. This review aims to detail the mechanism and clinical presentation of, and therapeutic strategies for, the treatment of DES in in-stent restenosis.