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.

A systematic review on the safety of second-generation transcatheter aortic valves.

AIMS: To review the outcomes of studies and the safety of newer transcatheter aortic valves (THV). METHODS AND RESULTS: All studies reporting on second-generation THV were identified and pooled using the systematic review guidelines. Twenty-four reports on 1,708 patients and eight THV were included in the analysis. The pooled 30-day event rate for mortality after transcatheter aortic valve implantation (TAVI) was 5.7% (95% CI: 4.0-7.8), myocardial infarction (MI) was 1.7% (95% CI: 1.1-2.6), stage 3 acute kidney injury (AKI) was 3.4% (95% CI: 2.0-5.6), life-threatening bleeding was 5.1% (95% CI: 3.3-7.8), major vascular complications was 4.9% (95% CI: 3.5-6.6%), major bleeding was 10.5% (95% CI: 5.1-20.4), major stroke was 2.4% (95% CI: 1.7-3.4), permanent pacemaker utilisation was 13.5% (95% CI: 10.8-16.9), and coronary obstruction was 1.2% (95% CI: 0.6%-2.4%). Moderate or severe aortic insufficiency (AI) after TAVI was 4.2% (95% CI: 2.0-8.5). The pooled 30-day mean gradient and effective orifice area (EOA) were 11.63 mmHg (95% CI: 10.19-13.07) and 1.60 cm2 (95% CI: 1.5-1.7), respectively. All estimates compare favourably to events reported for first-generation valves. CONCLUSIONS: Our findings suggest that the new THV have a low risk of TAVI-related short-term complications.

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.

Significance of aortic valve calcification in patients with low-gradient low-flow aortic stenosis.

BACKGROUND: Assessment of patients with aortic stenosis (AS) and impaired left ventricular function remains challenging. Aortic valve calcium (AVC) scoring with computed tomography (CT) and fluoroscopy has been proposed as means of diagnosing and predicting outcomes in patients with severe AS. HYPOTHESIS: Severity of aortic valve calcification correlates with the diagnosis of true severe AS and outcomes in patients with low-gradient low-flow AS. METHODS: Echocardiography and CT database records from January 1, 2000 to September 26, 2009 were reviewed. Patients with aortic valve area (AVA)<1.0 cm2 who had ejection fraction (EF)≤25% and mean valvular gradient≤25 mmHg with concurrent noncontrast CT scans were included. AVC was evaluated using CT and fluoroscopy. Mortality and aortic valve replacement (AVR) were established using the Social Security Death Index and medical records. The role of surgery in outcomes was evaluated. RESULTS: Fifty-one patients who met the above criteria were included. Mean age was 75.1±9.6 years, and 15 patients were female. Mean EF was 21%±4.6% with AVA of 0.7±0.1 cm2. The peak and mean gradients were 35.5±10.6 and 19.0±5.1 mmHg, respectively. Median aortic valve calcium score was 2027 Agatston units. Mean follow-up was 908 days. Patients with calcium scores above the median value were found to have increased mortality (P=0.02). The benefit of surgery on survival was more pronounced in patients with higher valvular scores (P=0.001). Fluoroscopy scoring led to similar findings, where increased AVC predicted worse outcomes (P=0.04). CONCLUSIONS: In patients with low-gradient low-flow AS, higher valvular calcium score predicts worse long-term mortality. AVR is associated with improved survival in patients with higher valve scores.

Left main coronary artery stenosis: a meta-analysis of drug-eluting stents versus coronary artery bypass grafting.

OBJECTIVES: The goal of this study was to provide a systematic review comparing the long-term outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary artery bypass graft surgery (CABG) for unprotected left main coronary artery (UPLM) stenosis. BACKGROUND: One-year outcomes from randomized controlled trials, observational studies, and pooled analyses have demonstrated the safety and efficacy of PCI of the UPLM when compared with CABG. However, there remain concerns over the sustainability of PCI with DES at longer follow-up. METHODS: Studies published between January 2000 and December 2012 of PCI versus CABG for UPLM stenosis were identified using an electronic search and reviewed using meta-analytical techniques. RESULTS: Twenty-four studies comprising 14,203 patients were included in the analysis. There was no significant difference for all-cause mortality between PCI or CABG at 1 year (odds ratio [OR]: 0.792, 95% confidence interval [CI]: 0.53 to 1.19), 2 years (OR: 0.920, 95% CI: 0.67 to 1.26), 3 years (OR: 0.94, 95% CI: 0.60 to 1.48), 4 years (OR: 0.84, 95% CI: 0.53 to 1.33), and 5 years (OR: 0.79, 95% CI: 0.57 to 1.08). The need for target vessel revascularization (TVR) was significantly higher in patients undergoing PCI at all time points. The occurrence of stroke, however, was significantly less frequent in patients treated with PCI. The occurrence of nonfatal myocardial infarction showed a statistically significant trend towards a lower incidence in CABG patients at 1 year (OR: 1.62, 95% CI: 1.05 to 2.50), 2 years (OR: 1.60, 95% CI: 1.09 to 2.35), and 3 years (OR: 2.06, 95% CI: 1.36 to 3.1). There was no significant difference in combined major adverse cardiovascular and cerebrovascular events between the 2 groups. CONCLUSIONS: Our findings suggest that PCI with DES is a safe and durable alternative to CABG for the revascularization of UPLM stenosis in select patients at long-term follow-up.

Concomitant percutaneous coronary intervention and transcatheter aortic valve replacement: safe and feasible replacement alternative approaches in high-risk patients with severe aortic stenosis and coronary artery disease.

OBJECTIVE: Transcatheter aortic valve replacement (TAVR) is performed as a stand-alone procedure in patients that are not suitable for surgical aortic valve replacement. However, a significant proportion of patients with severe aortic stenosis have coexisting coronary artery disease (CAD). We report concomitant TAVR and percutaneous coronary intervention (PCI) as a single procedure in such patients. METHODS: Three patients with severe aortic stenosis and CAD that were high risk for conventional surgery had concomitant alternative approach TAVR and PCI performed. Two patients had PCI and stent placement immediately after the deployment of the transapical transcatheter aortic valve, and one patient had a coronary artery stent placed just prior to the deployment of the transaortic transcatheter aortic valve. RESULTS: Two male patients and one female (age range 68-91 years) had 100% procedural success with resolution of symptoms and zero residual stenosis. There were no complications related to neurologic events, worsening renal function, or myocardial infarction. In-hospital and 30-day mortality was zero. All three patients were discharged home with a median hospital stay of eight days. CONCLUSIONS: In our small series of patients presented we demonstrate that PCI and TAVR performed concurrently in the hybrid operating room is a feasible option in patients undergoing TAVR with coexisting CAD. Furthermore, we propose this single-stage approach in such high-risk patients as it decreases the number of procedures performed and may theoretically lower cost and hospital stay.

Cardiogenic shock in the setting of severe aortic stenosis: role of intra-aortic balloon pump support.

OBJECTIVE: To investigate the haemodynamic effects of intra-aortic balloon pump (IABP) support in patients with severe aortic stenosis (AS) presenting in cardiogenic shock (CS). DESIGN: Observational cohort study. Setting Tertiary academic centre coronary intensive care unit (CICU). Patients Patients presenting to the CICU in CS with an established diagnosis of AS (n=25 with mean age (± SD) of 73.5 ± 9.5 years). The peak and mean Doppler AV gradients were 67 ± 26.8 mm Hg and 39.8 ± 16.8 mm Hg, respectively, with a mean baseline cardiac index of 1.77 ± 0.38 l/min/m²). Interventions Utilisation of IABP. Main outcome measures Haemodynamic impact of IABP over time. RESULTS: With the insertion of an IABP, patients' cardiac index improved from 1.77 l/min/m² to 2.18 and 2.36 l/min/m² at 6 and 24 h, respectively (p<0.001 for both times points). Systemic vascular resistance was reduced from 1331 dyn/s/cm5 to 1265 and 1051 dyn/s/cm5 at 6 and 24 h, respectively (p=0.66 and p=0.005, respectively). The central venous pressure was reduced from 14.8 mm Hg to 13.2 and 10.9 mm Hg at 6 and 24 h, respectively (p=0.12 and p=0.03, respectively). IABP insertion was associated with a complication in 3 of the 25 cases, including a deep vein thrombosis, thrombocytopenia, limb ischaemia, and technical malfunctioning of the device. CONCLUSIONS: IABP support improves the haemodynamic profile in patients with severe AS who present in CS. IABP utilisation in this critically ill population should be strongly considered as patients are being evaluated for candidacy for advanced interventions.

Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications.

Transcatheter aortic valve implantation (TAVI) is becoming a reality in the management of patients with severe aortic stenosis and high or prohibitive risk for standard surgical management. Current understanding of the potential adverse events associated with this procedure is limited. Risks associated with TAVI differ from those related to surgical valve replacement and include vascular injury; stroke; cardiac injury such as heart block, coronary obstruction, and cardiac perforation; paravalvular leak; and valve misplacement. The clinical experience of multiple centers experience with different valve implantation systems and techniques was reviewed. Awareness of how complications occur might help in their avoidance, recognition, and management. Ultimately, improved understanding of the potential complications associated with TAVI might help improve outcomes and allow wider application of this therapy.