The planning of revascularization strategy for multivessel coronary artery disease (CAD) in nondiabetic patients is optimally made through considering the goals of improving survival and/or relieving symptoms. Existing clinical practice guidelines and appropriate use criteria (1–3) state that in nondiabetic patients with multivessel CAD and stable ischemic heart disease (SIHD), either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) with drug-eluting stents may be used for those with low SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores, but CABG is preferred for those with intermediate or high SYNTAX scores. In the overall SYNTAX population (4–6), the rates of death and stroke were similar, but the risk of myocardial infarction (MI) and repeat revascularization were higher in PCI-treated patients. At 5-year follow-up, the rates of death/stroke/MI are 8.0% lower, and the rate of repeat revascularization is 12.8% lower in CABG-treated patients. In the low SYNTAX score tertile, these trends are not significantly different, but they are in the intermediate and high SYNTAX score subsets. When considering only survival in the 3 tertiles, there was a 0.9%, 6.7%, and 9.0% difference over 5 years, an average of 0.2% to 1.8% per year. Yet, PCI is more often performed in multivessel CAD patients, despite the guidelines and clinical evidence. Can this apparent divergence from the evidence base be supported? Drs. Weintraub and Tcheng and colleagues were asked to defend or critique the current guidelines.
Objectives: This study sought to use a new catheter technique to split the anterior mitral valve leaflet (AML) and prevent iatrogenic left ventricular outflow tract (LVOT) obstruction immediately before transcatheter mitral valve replacement (TMVR).
Background: LVOT obstruction is a life-threatening complication of TMVR, caused by septal displacement of the AML.
Methods: The procedure was used in patients with severe mitral valve disease and prohibitive surgical risk. Patients either had prior surgical mitral valve ring (n = 3) or band annuloplasty (n = 1) or mitral annular calcification with stenosis (n = 1). Iatrogenic LVOT obstruction or transcatheter heart valve dysfunction was predicted in all based on echocardiography and computed tomography. Transfemoral coronary guiding catheters directed an electrified guidewire across the center and base of the AML toward a snare in the left atrium. The externalized guidewire loop was then electrified to lacerate the AML along the centerline from base to tip, sparing chordae, immediately before transseptal TMVR.
Results: Five patients with prohibitive risk of LVOT obstruction or transcatheter heart valve dysfunction from TMVR successfully underwent LAMPOON, with longitudinal splitting of the A2 scallop of the AML, before valve implantation. Multiplane computed tomography modeling predicted hemodynamic collapse from TMVR assuming an intact AML. However, critical LVOT gradients were not seen following LAMPOON and TMVR. Doppler blood flow was seen across transcatheter heart valve struts that encroached the LVOT, because the AML was split. Transcatheter heart valve function was unimpeded.
Conclusions: This novel catheter technique, which resembles surgical chord-sparing AML resection, may enable TMVR in patients with prohibitive risk of LVOT obstruction or transcatheter heart valve dysfunction.
Objectives: This study sought to develop a novel technique called bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction (BASILICA).
Background: Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR). Methods: We lacerated pericardial leaflets in vitro using catheter electrosurgery, and tested leaflet splaying after benchtop TAVR. The procedure was tested in swine. BASILICA was then offered to patients at high risk of coronary obstruction from TAVR and ineligible for surgical aortic valve replacement. BASILICA used marketed devices. Catheters directed an electrified guidewire to traverse and lacerate the aortic leaflet down the center line. TAVR was performed as usual.
Results: TAVR splayed lacerated bovine pericardial leaflets. BASILICA was successful in pigs, both to left and right cusps. Necropsy revealed full length lacerations with no collateral thermal injury. Seven patients underwent BASILICA on a compassionate basis. Six had failed bioprosthetic valves, both stented and stent-less. Two had severe aortic stenosis, including 1 patient with native disease, 3 had severe aortic regurgitation, and 2 had mixed aortic valve disease. One patient required laceration of both left and right coronary cusps. There was no hemodynamic compromise in any patient following BASILICA. All patients had successful TAVR, with no coronary obstruction, stroke, or any major complications. All patients survived to 30 days.
Conclusions: BASILICA may durably prevent coronary obstruction from TAVR. The procedure was successful across a range of presentations, and requires further evaluation in a prospective trial. Its role in treatment of degenerated TAVR devices remains untested.
by
Jaffar M. Khan;
Toby Rogers;
William H. Schenke;
Jonathan R. Mazal;
Anthony Z. Faranesh;
Adam B. Greenbaum;
Vasilis Babaliaros;
Marcus Y. Chen;
Robert J. Lederman
OBJECTIVES: The authors propose a novel transcatheter transection of the anterior mitral leaflet to prevent iatrogenic left ventricular outflow tract (LVOT) obstruction during transcatheter mitral valve replacement (TMVR).
BACKGROUND: LVOT obstruction is a life-threatening complication of TMVR caused by septal displacement of the anterior mitral leaflet. METHODS: In vivo procedures in swine were guided by biplane x-ray fluoroscopy and intracardiac echocardiography. Retrograde transaortic 6-F guiding catheters straddled the anterior mitral leaflet. A stiff 0.014-inch guidewire with polymer jacket insulation was electrified and advanced from the LVOT, through the A2 leaflet base, into the left atrium. The wire was snared and externalized, forming a loop that was energized and withdrawn to lacerate the anterior mitral leaflet.
RESULTS: The anterior mitral leaflet was successfully lacerated in 7 live and 1 post-mortem swine under heparinization. Lacerations extended to 89 ± 19% of leaflet length and were located within 0.5 ± 0.4 mm of leaflet centerline. The chordae were preserved and retracted the leaflet halves away from the LVOT. LVOT narrowing after benchtop TMVR was significantly reduced with intentional laceration of the anterior mitral leaflet to prevent LVOT obstruction than without (65 ± 10% vs. 31 ± 18% of pre-implantation diameter, p < 0.01). The technique caused mean blood pressure to fall (from 54 ± 6 mm Hg to 30 ± 4 mm Hg, p < 0.01), but blood pressure remained steady until planned euthanasia. No collateral tissue injury was identified on necropsy.
CONCLUSIONS: Using simple catheter techniques, the anterior mitral valve leaflet was transected. Cautiously applied in patients, this strategy can prevent anterior mitral leaflet displacement and LVOT obstruction caused by TMVR.
by
Brian R. Lindman;
William J. Stewart;
Philippe Pibarot;
Rebecca T. Hahn;
Catherine M. Otto;
Ke Xu;
Richard B. Devereux;
Neil J. Weissman;
Maurice Enriquez-Sarano;
Wilson Y. Szeto;
Raj Makkar;
D. Craig Miller;
Stamatios Lerakis;
Samir Kapadia;
Bruce Bowers;
Kevin L. Greason;
Thomas C. McAndrew;
Yang Lei;
Martin B. Leon;
Pamela S. Douglas
Objectives This study sought to examine the relationship between left ventricular mass (LVM) regression and clinical outcomes after transcatheter aortic valve replacement (TAVR). Background LVM regression after valve replacement for aortic stenosis is assumed to be a favorable effect of LV unloading, but its relationship to improved clinical outcomes is unclear. Methods Of 2,115 patients with symptomatic aortic stenosis at high surgical risk receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) randomized trial or continued access registry, 690 had both severe LV hypertrophy (left ventricular mass index [LVMi] 149 g/m2 men, 122 g/m2 women) at baseline and an LVMi measurement at 30-day post-TAVR follow-up. Clinical outcomes were compared for patients with greater than versus lesser than median percentage change in LVMi between baseline and 30 days using Cox proportional hazard models to evaluate event rates from 30 to 365 days. Results Compared with patients with lesser regression, patients with greater LVMi regression had a similar rate of all-cause mortality (14.1% vs. 14.3%, p = 0.99), but a lower rate of rehospitalization (9.5% vs. 18.5%, hazard ratio [HR]: 0.50, 95% confidence interval [CI]: 0.32 to 0.78; p = 0.002) and a lower rate of rehospitalization specifically for heart failure (7.3% vs. 13.6%, p = 0.01). The association with a lower rate of rehospitalization was consistent across subgroups and remained significant after multivariable adjustment (HR: 0.53, 95% CI: 0.34 to 0.84; p = 0.007). Patients with greater LVMi regression had lower B-type natriuretic peptide (p = 0.002) and a trend toward better quality of life (p = 0.06) at 1-year follow-up than did those with lesser regression. Conclusions In high-risk patients with severe aortic stenosis and severe LV hypertrophy undergoing TAVR, those with greater early LVM regression had one-half the rate of rehospitalization over the subsequent year compared to those with lesser regression.
by
Jean-Michel Paradis;
Hersh S. Maniar;
John M. Lasala;
Susheel Kodali;
Mathew Williams;
Brian R. Lindman;
Ralph J. Damiano;
Marc R. Moon;
Marc R. Makkar;
Vinod Thourani;
Vasilis Babaliaros;
Ke Xu;
Girma Minalu Ayele;
Lars Svensson;
Martin B. Leon;
Alan Zajarias
Objectives This study sought to clarify the clinical and echocardiographic prognostic implication of myocardial injury after transcatheter aortic valve replacement (TAVR). Background The clinical significance of cardiac biomarker elevation after TAVR remains unclear. Methods Patients treated with TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial were divided into tertiles (T1, T2, T3) based on the difference between the values on post-procedure day 1 and the baseline values of 2 cardiac biomarkers: cardiac troponin I (ΔcTnI); and creatine kinase-myocardial band (ΔCK-MB) fraction. Patients were stratified according to their access route: transfemoral (TF) (n = 1,840) or transapical (TA) (n = 1,173). Results At 30 days after TF-TAVR, patients in the highest tertile (T3) of cardiac biomarker elevation had a higher rate of all-cause mortality (ΔcTnI: T3: 5.4% vs. T1: 0.5%, p = 0.006; ΔCK-MB: T3: 5.7% vs. T1: 0.9%, p = 0.006) and cardiovascular mortality (ΔcTnI: T3: 4.9% vs. T1: 0.5%, p = 0.01; ΔCK-MB: T3: 3.9% vs. T1: 0.5%, p = 0.02). At 1 year, only patients in the highest CK-MB tertile had higher rates of all-cause (25.4% vs. 16.8%, p = 0.02) and cardiovascular (10.3% vs. 5.0%) mortality. Multivariable analysis demonstrated that greater release of cardiac biomarkers was independently associated with increased mortality in the TF population. After TA-TAVR, being in the highest tertile of cardiac biomarker elevation had no influence on clinical and echocardiographic outcomes at 30 days and 1 year. Conclusions After TF-TAVR, a greater degree of myocardial injury was associated with higher rates of 30-day all-cause and cardiovascular mortality. At 1 year, being in the highest tertile of ΔCK-MB was correlated with a higher rate of all-cause and cardiac mortality. Finally, the level of myocardial injury after TA-TAVR had no impact on clinical and echocardiographic outcomes.
by
Janet Wei;
Puja Kiran Mehta;
B. Delia Johnson;
Bruce Samuels;
Saibal Kar;
R. David Anderson;
Babak Azarbal;
John Petersen;
Barry Sharaf;
Eileen Handberg;
Chrisandra Shufelt;
Kamlesh Kothawade;
George Sopko;
Amir Lerman;
Leslee J Shaw;
Sheryl F. Kelsey;
Carl J. Pepine;
C. Noel Bairey Merz
Objectives: This study evaluated the safety of coronary reactivity testing (CRT) in symptomatic women with evidence of myocardial ischemia and no obstructive coronary artery disease (CAD). Background: Microvascular coronary dysfunction (MCD) in women with no obstructive CAD portends an adverse prognosis of a 2.5% annual major adverse cardiovascular event (MACE) rate. The diagnosis of MCD is established by invasive CRT, yet the risk of CRT is unknown. Methods: The authors evaluated 293 symptomatic women with ischemia and no obstructive CAD, who underwent CRT at 3 experienced centers. Microvascular function was assessed using a Doppler wire and injections of adenosine, acetylcholine, and nitroglycerin into the left coronary artery. CRT-related serious adverse events (SAEs), adverse events (AEs), and follow-up MACE (death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization for heart failure) were recorded. Results: CRT-SAEs occurred in 2 women (0.7%) during the procedure: 1 had coronary artery dissection, and 1 developed MI associated with coronary spasm. CRT-AEs occurred in 2 women (0.7%) and included 1 transient air microembolism and 1 deep venous thrombosis. There was no CRT-related mortality. In the mean follow-up period of 5.4 years, the MACE rate was 8.2%, including 5 deaths (1.7%), 8 nonfatal MIs (2.7%), 8 nonfatal strokes (2.7%), and 11 hospitalizations for heart failure (3.8%). Conclusions: In women undergoing CRT for suspected MCD, contemporary testing carries a relatively low risk compared with the MACE rate in these women. These results support the use of CRT by experienced operators for establishing definitive diagnosi s and assessing prognosis in this at-risk population. (Women's Ischemia Syndrome Evaluation [WISE] ; NCT00832702).
Objectives: The purpose of this study was to assess the pathological responses of atherosclerotic saphenous vein bypass grafts (SVBGs) to drug-eluting stents (DES) versus bare-metal stents (BMS). Background: Repeat bypass surgery is typically associated with a high rate of morbidity and mortality. Percutaneous coronary interventions have emerged as the preferred treatment; however, only limited data are available on SVBGs pathological responses to DES and BMS. Methods: Formalin-fixed SVBG of > 2 years duration (n = 31) were collected to histologically characterize advanced atherosclerotic lesions in native SVBG. In a separate group, SVBGs treated with DES (n = 9) and BMS (n = 9) for > 30 days duration were assessed for morphological and morphometric changes. Results: Necrotic core lesions were identified in 25% of SVBG sections, and plaque rupture with luminal thrombosis was observed in 6.3% of histological sections (32% [10 of 31] vein grafts examined). Morphometry of DES demonstrated reduction in neointimal thickening versus BMS (0.13 mm [interquartile range: 0.06 to 0.16 mm] vs. 0.30 mm [interquartile range: 0.20 to 0.48 mm], p = 0.004). DES lesions also showed greater delayed healing characterized by increased peristrut fibrin deposition, higher percentage of uncovered struts, and less endothelialization compared with BMS. Stent fractures (DES 56% vs. BMS 11%, p = 0.045) and late stent thrombosis (DES 44% vs. BMS 0%, p = 0.023) were more common in DES versus BMS. Conclusions: Advanced SVBG atherosclerotic lesions are characterized by large hemorrhagic necrotic cores. Stenting of such lesions is associated with delayed vascular healing and late thrombosis particularly following DES implantation, which may help explain the higher rates of cardiovascular events observed in SVBG stenting as compared with native coronary arteries.