Steven L. Goldberg

Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial

Functional mitral regurgitation (FMR) contributes to morbidity and mortality in heart failure (HF) patients. The aim of this study was to determine whether percutaneous mitral annuloplasty could safely and effectively reduce FMR and yield durable long‐term clinical benefit.

A Randomized Controlled Trial of Angiography Versus Intravascular Ultrasound-Directed Bare-Metal Coronary Stent Placement (The AVID Trial)

Background—AVID (Angiography Versus Intravascular ultrasound-Directed stent placement) is a multicenter, randomized controlled trial designed to assess the effect of intravascular ultrasound (IVUS)-directed stent placement on the 12-month rate of target lesion revascularization (TLR). Methods and Results—After elective coronary stent placement and an optimal angiographic result (<10% stenosis), 800 patients were randomized to Angiography- or IVUS-directed therapy. Blinded IVUS was performed in the Angiography group without further therapy. In the IVUS group, IVUS criteria for optimal stent placement (<10% area stenosis, apposition, and absence of dissection) were applied. Final minimum stent area was 6.90±2.43 mm2 in the Angiography group and 7.55±2.82 mm2 in the IVUS group (P=0.001). In the IVUS group, only 37% with inadequate expansion (<90%) received further therapy. The 12-month TLR rate was 12.0% in the Angiography group and 8.1% in the IVUS group (P=0.08, 95% confidence level [CI], [−8.3% to 0.5%]). When vessels with a distal reference diameter <2.5 mm by core laboratory angiography measurement were excluded from analysis, the 12-month TLR rate was 10.1% in the Angiography group and 4.3% in the IVUS group (P=0.01, 95% CI, [−10.6% to −1.2%]). With a prestent angiographic stenosis of ≥70%, the TLR rate was lower in the IVUS group compared with the Angiography group (3.1% versus 14.2%; P=0.002; 95% CI, [−18.4% to −4.2%]). Conclusions—IVUS-directed bare-metal stent placement results in larger acute stent dimensions without an increase in complications and a significantly lower 12-month TLR rate for vessels ≥2.5 mm by angiography and for vessels with high-grade prestent stenosis. However, for the entire sample analyzed on an intention-to-treat basis, IVUS-directed bare-metal stent placement does not significantly reduce the 12-month TLR rate when compared with stent placement guided by angiography alone. In addition, IVUS evaluation of adequate stent expansion is underutilized by experienced operators.

Prognostic Impact of Periprocedural Bleeding and Myocardial Infarction After Percutaneous Coronary Intervention in Unselected Patients: Results From the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) Registry

OBJECTIVES Our aim was to examine the prognostic importance of hemorrhagic and ischemic complications after percutaneous coronary intervention (PCI) in unselected patients. BACKGROUND In randomized trials of PCI, major bleeding and periprocedural myocardial infarction (pMI) have been associated with increased mortality. Whether similar associations exist among un-selected PCI patients is unknown. METHODS We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry-a multicenter registry of unselected patients undergoing PCI-to examine the association between both in-hospital bleeding and pMI and 1-year mortality. Cardiac enzyme levels were assessed in all patients, and pMI was defined as a peak creatine kinase-MB value >or=3x the upper limit of normal. Post-PCI bleeding was classified by Thrombolysis In Myocardial Infarction criteria. RESULTS After excluding patients with elevated pre-PCI creatine kinase-MB values and ST-segment elevation myocardial infarction at presentation (n = 1,626), a total of 5,961 patients were available for evaluation. Rates of post-PCI bleeding and pMI were 3.0% and 7.1%, respectively; 1-year all-cause mortality was 2.8%. After multivariable adjustment, both post-PCI bleeding (adjusted hazard ratio [HR]: 3.83, 95% confidence interval: 2.48 to 5.90, p < 0.001) and pMI (adjusted HR: 1.84, 95% confidence interval: 1.17 to 2.89, p = 0.009) were independently associated with 1-year mortality. Time period-specific analyses demonstrated that the adjusted HR for bleeding was similar for 30-day mortality and mortality between 1 month and 1 year, while the adjusted HR for pMI was greater for 30-day mortality as compared with mortality between 1 month and 1 year. CONCLUSIONS Among unselected PCI patients, both post-PCI bleeding and pMI are independently associated with increased 1-year mortality. Continued efforts to reduce these complications after PCI are warranted.

Prevalence and prognostic significance of preprocedural cardiac troponin elevation among patients with stable coronary artery disease undergoing percutaneous coronary intervention: results from the evaluation of drug eluting stents and ischemic events registry.

Background— Although cardiac troponin (cTn) elevation is associated with periprocedural complications during percutaneous coronary intervention (PCI) in the setting of acute coronary syndromes, the prevalence and prognostic significance of preprocedural cTn elevation among patients with stable coronary artery disease undergoing PCI are unknown. Methods and Results— Between July 2004 and September 2006, 7592 consecutive patients who underwent attempted stent placement at 47 hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed the frequency of an elevated cTn immediately before PCI and its relationship to in-hospital and 1-year outcomes among patients who underwent PCI for either stable angina or a positive stress test. Among the stable coronary artery disease population (n=2382, 31.4%), 142 (6.0%) had a cTn level above the upper limit of normal before the procedure. Compared with patients who had normal baseline cTn, patients with elevated cTn had a higher rate of in-hospital death or myocardial infarction (13.4% versus 5.6%; P<0.001) and a trend toward higher rates of urgent repeat PCI (1.4% versus 0.2%; P=0.06). In multivariable analyses adjusted for demographic, clinical, angiographic, and procedural factors, baseline cTn elevation remained independently associated with the composite of death or myocardial infarction at hospital discharge (odds ratio, 2.1; 95% confidence interval, 1.2 to 3.8; P=0.01) and at the 1-year follow-up (odds ratio, 2.0; 95% confidence interval, 1.2 to 3.3; P=0.005). Conclusions— Baseline elevation of cTn is relatively common among patients with stable coronary artery disease undergoing PCI and is an independent prognostic indicator of ischemic complications. If these data are confirmed in future studies, consideration should be given to routine testing of cTn before performance of PCI in this patient population.

How does warfarin affect the activated coagulation time

BACKGROUND The activated coagulation time (ACT) is a rapid measurement of a patients level of heparin anticoagulation during cardiac catheterization. Patients receiving warfarin therapy occasionally are seen at the catheterization laboratory for emergent procedures. The effects of warfarin on ACT activity have not been previously described. We compared the ACT and the international normalized ratios (INR) in 77 patients receiving warfarin and 57 patients who were not receiving any anticoagulation (controls). RESULTS Both the mean ACT (131+/-17.0 seconds) and INR (2.5+/-0.90 seconds) of the anticoagulated patients differed from the controls (ACT=115+/-14.5 seconds, INR=1.0+/-0.10 seconds; P< 0.05). The ACT increased linearly with INR in the warfarin group (r=0.70, P< .001). There was no relation between ACT and INR in the control group. CONCLUSION Patients receiving warfarin therapy will have a linear increase in ACT develop similar to patients receiving heparin therapy.

Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER Multicenter Registry†

The BARASTER registry was formed to evaluate the initial success and long‐term results of rotational atherectomy in the management of in‐stent restenosis. Rotational atherectomy was used in 197 cases of in‐stent restenosis: 46 with stand‐alone rotational atherectomy or at most 1 atmosphere of balloon inflation (Rota strategy), and 151 with rotational atherectomy and adjunctive balloon angioplasty <1 atmosphere (Combination strategy). These were compared with 107 episodes of in‐stent restenosis treated with balloon angioplasty alone. In this observational study, the use of Combination therapy was associated with a slightly higher initial success rate (95% vs. 87% with the Rota strategy and 89% with Balloons, P = 0.08). There was a reduction in one year clinical outcomes (death, myocardial infarction or target lesion revascularization) in the combination group (38% vs. 60% with Rota and 52% with balloons, P = 0.02). These data support a benefit of the strategy of debulking with rotational atherectomy followed by adjunctive balloon angioplasty, in the management of in‐stent restenosis. Cathet. Cardiovasc. Intervent. 51:407–413, 2000.

Screening Stress Myocardial Perfusion Imaging and Eligibility for Liver Transplantation

Screening for coronary artery disease is common practice in the evaluation of liver transplantation candidates. However, it is unclear whether coronary screening influences transplantation eligibility. We sought to determine the association between screening stress myocardial perfusion imaging (MPI) results and the eligibility for liver transplantation. Within a retrospective cohort of liver transplantation candidates referred for screening stress MPI at a single institution from April 1998 to February 2004, we obtained the baseline characteristics, stress MPI results, transplantation eligibility, and transplantation denial criteria by chart review. Of 294 patients (39%) denied transplantation, the denial criteria were multifactorial for 91 (31%) of the candidates. Compared to candidates with low-risk stress MPI results, the odds of being denied transplantation were the same for candidates with intermediate-risk MPI results (odds ratio 0.93, 95% confidence interval 0.45 to 1.82) or high-risk MPI results (odds ratio 1.42, 95% confidence interval 0.54 to 3.73). This lack of association persisted in our analysis with additional stratification of stress MPI results into negative, positive-low-risk, positive-intermediate-risk, and positive-high-risk. In conclusion, the screening stress MPI results were not associated with liver transplantation eligibility. The large number of competing factors considered before transplantation listing and the low proportion of positive stress MPI results suggests that targeting screening to patients deemed otherwise acceptable for transplantation might increase the influence of stress MPI findings on transplantation eligibility.

Percutaneous Mitral Valve Interventions: Overview of New Approaches

The percutaneous management of valvular heart disease has recently been receiving a great deal of interest as an area of great potential. Innovative technologies are now being developed to treat mitral regurgitation. Although there are established surgical techniques for treating organic mitral regurgitation, the surgical management of functional mitral regurgitation remains controversial, and such patients have a poor prognosis. Therefore, a percutaneous treatment for functional mitral regurgitation holds great clinical potential. Having a nonsurgical approach available may be attractive to patients with organic mitral valve regurgitation as well. Several approaches and devices have been designed to treat specifically functional mitral regurgitation, and some of these have been applied to humans in early-stage evaluations. The MitraClip device (Abbott Laboratories, Abbott Park, IL) has been used to treat both functional and degenerative mitral valve regurgitation and has been compared to surgery in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) randomized trial. Although the field of percutaneous management of mitral regurgitation is at an early stage, it has been demonstrated that percutaneous approaches can reduce mitral regurgitation, suggesting there is a great deal of potential for clinical benefit to patients with mitral regurgitation.

The society for cardiovascular angiography and interventions structural heart disease early career task force survey results: Endorsed by the society for cardiovascular angiography and interventions†

Over the last decade, structural heart disease interventions have emerged as a new field in interventional cardiology. Currently, the Accreditation Council for Graduate Medical Education accredited interventional cardiology fellowship programs in the United States provide high‐quality and well established training curriculum in coronary and peripheral interventions, but training in structural interventions remains in its infancy. The current survey seeks to collect relevant information and assess the opinion of interventional cardiology program directors in ACGME‐accredited institutions that are actively involved in structural interventional training. Our study describes the actual number of structural procedures performed by interventional cardiology fellows in ACGME‐accredited programs, the form of the structural training today and the suggestions from program directors who are actively trying to integrate structural training in the interventional cardiology fellowship programs.

In-hospital and 1-year outcomes among unselected percutaneous coronary intervention patients treated with either sirolimus- or paclitaxel-eluting stents: results from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry.

OBJECTIVES The aim of this study was to compare outcomes among unselected patients undergoing percutaneous coronary intervention (PCI) with either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES). BACKGROUND Although the benefits of both SES and PES are well-established, studies comparing these stents directly have yielded conflicting results. METHODS We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry to compare in-hospital and 1-year outcomes among unselected patients undergoing nonemergent PCI with either SES or PES implantation. RESULTS Between July 2004 and June 2006, 6,035 patients underwent PCI with either SES (n = 3,443) or PES (n = 2,592) at 47 U.S. centers. Baseline clinical and angiographic characteristics were generally similar for the 2 stent types. At 1-year, there were no differences in the primary end point of cardiac death or myocardial infarction (MI) between the SES and PES groups (9.1% vs. 10.0%, p = 0.11) or in any individual end points including cardiac death, nonfatal MI, or stent thrombosis. In unadjusted analyses, target lesion revascularization (TLR) was slightly more common with SES than with PES (4.4% vs. 3.3%, p = 0.048), but this difference was no longer apparent after adjusting for baseline characteristics as well as site-related factors (adjusted hazard ratio: 1.09, 95% confidence interval: 0.78 to 1.50). CONCLUSIONS Among unselected patients undergoing PCI, adjusted rates of both ischemic complications as well as clinically important restenosis were similar for SES and PES. The unexpected finding that TLR was influenced by site characteristics suggests that the correlation between TLR and angiographic restenosis might be weaker than previously described and warrants further study.