Mitral Valve Replacement With Sapien 3 Transcatheter Valve in Severe Mitral Annular Calcification.

Transcatheter valve implantation in the mitral position with severe calcific mitral stenosis has been described in patients who are at an increased risk for conventional mitral valve surgical procedures. We report the direct deployment of the Sapien 3 valve in the mitral position with severe mitral annular calcification through a sternotomy in an arrested heart in two cases.

Performance of currently available risk models in a cohort of mechanically supported high-risk percutaneous coronary intervention--From the PROTECT II randomized trial.

BACKGROUND: Procedural risk scores facilitate clinical decision making by using individual patient characteristics to estimate the risk of adverse events. The performance of PCI-based risk scores is not well-described among patients undergoing hemodynamically supported high risk PCI. METHODS AND RESULTS: A total of 427 patients with unprotected left main disease, last remaining vessel or three-vessel disease with severely reduced left ventricular function underwent supported high-risk PCI with an intra-aortic balloon pump (IABP, N = 211) or a left ventricular assist device (Impella 2.5, N = 216) as part of the PROTECT II trial. We examined the performance of the additive Euroscore, logistic Euroscore, STS mortality score, STS morbidity and mortality score, Mayo Clinic risk score and New York state PCI risk score on the endpoint of 90-day mortality in this unique high-risk population. Mean age was 67.2 ± 10.9 years; 65.8% of patients were in NYHA class III/IV, and mean LVEF was 24%. All-cause 90-day mortality was 10.4%. The scores were generally correlated (p < 0.0001 for all comparisons), with R(2) values ranging from 0.28 (STS morbidity/mortality and Mayo Clinic) to 0.68 (logistic Euroscore and STS mortality). However, receiver-operator curves for 90-day all-cause mortality for all risk scores demonstrated poor discriminatory performance with c-statistics of 0.542-0.616. Calibration of the risk scores was not poor, but varied according to the specific score examined. CONCLUSION: The discriminatory capacity of currently available risk models is suboptimal when applied to a cohort of mechanically supported complex high-risk PCI. A risk score designed specifically for this population could help to further refine risk assessment.

A randomized, double-blind, placebo-controlled, multicenter, pilot study of the safety and feasibility of catheter-based intramyocardial injection of AdVEGF121 in patients with refractory advanced coronary artery disease.

BACKGROUND: The experience with direct myocardial injection of adenovirus encoding angiogenic growth factor is limited to invasive surgical approach. Accordingly, we sought to evaluate, for the first time, in a randomized, double-blind, placebo-controlled, phase I pilot study the safety and feasibility of percutaneous catheter-based intramyocardial delivery of a replication-deficient adenovector encoding the 121-amino-acid isoform of vascular endothelial growth factor (AdVEGF121). METHODS: Ten "no-option" patients with severe coronary artery disease were randomized (2:1) to receive AdVEGF121 (4 x 10(10) pu) or placebo as fifteen 100 microL, evenly distributed, endomyocardial injections using a nonflouroscopic, 3-dimensional mapping and injection (NOGA) catheter-based system. RESULTS: Injection procedure was successfully completed in all cases and was associated with no major adverse events. AdVEGF121 was considered potentially associated with a single serious adverse event of transient moderate fever. Elevated postprocedure CK and CK-MB fraction levels were recorded in two placebo-treated and three AdVEGF121-treated patients; all CK measured values were <1.5 times upper limit of normal. All adenoviral cultures (urine and throat swab) were negative 24-hr after dosing, and no significant changes in serial plasma VEGF levels were noted over time. At 12 months follow-up, no cancers, proliferative retinal changes, or significant abnormalities in hepatic, renal or hematological indices were observed. CONCLUSIONS: Percutaneous, catheter-based AdVEGF121 intramyocardial injection is a practical, feasible, and potentially safe approach for intramyocardial gene transfer. A larger randomized, phase II efficacy study is warranted.

Two-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial.

OBJECTIVES: The purpose of this study was to examine the two-year clinical outcomes in patients enrolled in the Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (SIRIUS) study. BACKGROUND: The SIRIUS study was a double-blinded randomized study which demonstrated that sirolimus-eluting stents (SES) significantly improved angiographic results (at 8 months) and clinical outcomes (at 9 and 12 months) compared with bare-metal stents (BMS). METHODS: Patients with de novo native coronary artery lesions randomized to either SES (533 patients) or control BMS (525 patients) were followed for two years. RESULTS: Between one and two years, there were infrequent additional clinical events that were equally distributed between the sirolimus and control groups. After two years, target lesion revascularization was 5.8% and 21.3% in SES and control patients, respectively (p < 0.001), and major adverse cardiovascular events and target vessel failure rates were 10.1% versus 24.4% and 12.0% versus 26.7%, respectively (p < 0.0001 for both). There were no differences in death, myocardial infarction, and stent thrombosis between the two groups. CONCLUSIONS: Clinical outcomes two years after implantation of SES continue to demonstrate significant reduction in the need for repeat target lesion (and vessel) revascularization compared with BMS without evidence for either disproportionate late restenosis or late stent thrombosis.

Rotational Atherectomy in Octogenarians: Results and Follow Up.

We examined our first 390 rotational atherectomy procedures to determine success and complications rates of patients aged 80 or greater (Group I, N equals 35) as compared to those younger (Group II, N equals 355). Procedural success was achieved in 32/35 (91%) of Group I and 42/355 (96%) of Group II patients (p equals NS). Coronary artery bypass graft surgery was required in 2/35 (5.7%) of Group I and 7/355 (2%) of Group II patients. No deaths, Q wave infarctions, or perforations occurred in the elderly patients and only one of each was observed in the younger group. During clinical follow up (26 months, 3-50), 4/25 patients (16%) in the octogenarian group died. Two of the deaths were cardiac (including the only crossover to surgery). One patient who sustained a late non Q myocardial infarction was asymptomatic. Of the remaining 20 patients the anginal class was 0-II in 19 and III in one. Rotational atherectomy can achieve excellent short and long term outcomes in selected octogenarians. (c)2000 by CVRR, Inc.