Sameer Arora

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis

BACKGROUND Transcatheter aortic valve replacement (TAVR) has been approved in patients with high or prohibited surgical risk for surgery for treatment of severe symptomatic aortic stenosis. Prospective studies examining the benefits of TAVR in intermediate risk patients are ongoing. Other smaller studies including lower risk patients have been conducted, but further meta-analysis of these studies is required to draw more broad comparisons. METHODS A Medline search was conducted using standard methodology to search for clinical trials and observational studies including intermediate risk patients. We limited our meta-analysis to studies matching patient populations by propensity scores or randomization and examined clinical outcomes between TAVR and surgical aortic valve replacement (SAVR). RESULTS Analysis of the TAVR and SAVR cohorts revealed no significant differences in the outcomes of 30-day [OR (95% CI): 0.85 (0.57, 1.26)] or 1-year mortality [OR (95% CI): 0.96 (0.75, 1.23)]. A trend towards benefit with TAVR was noted in terms of neurological events and myocardial infarction (MI) without statistical significance. A statistically significant decrease in risk of post-procedural acute renal failure in the TAVR group [OR (95% CI): 0.52 (0.27, 0.99)] was observed, but so was a significantly higher rate of pacemaker implantations for the TAVR group [OR (95% CI): 6.51 (3.23, 13.12)]. CONCLUSIONS We conclude that in intermediate risk patients undergoing aortic valve replacement, the risk of mortality, neurological outcomes, and MI do not appear to be significantly different between TAVR and SAVR. However, there appears to be a significant reduction in risk of acute renal failure at the expense of an increased risk of requiring a permanent pacemaker in low and intermediate risk patients undergoing TAVR compared to SAVR.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Lower Surgical Risk Scores: A Systematic Review and Meta-Analysis of Early Outcomes

BACKGROUND The results from the PARTNER 2 trial showed the feasibility of transcatheter aortic valve replacement (TAVR) in intermediate surgical risk patients. Although low risk clinical trials will take time to conclude, some data has emerged comparing TAVR with surgical aortic valve replacement (SAVR) in lower risk patients. METHODS A Medline search was conducted using standard methodology to search for studies reporting results comparing TAVR and SAVR. Studies were included if the overall mean Society of Thoracic Surgeons Score was less than 4% (or equivalent Euroscore). A meta-analysis comparing the 30-day risk of clinical outcomes between TAVR and SAVR in the lower surgical risk population was conducted. RESULTS A total of four studies, including one clinical trial and three propensity-matched cohort studies met the inclusion criteria. Compared to SAVR, TAVR had a lower risk of 30-day mortality (RR 0.67, 95% CI 0.41, 1.10), stroke (RR 0.60, 95% CI 0.30, 1.22), bleeding complications (RR 0.51, 95% CI 0.40, 0.67) and acute kidney injury (RR 0.66, 95% CI 0.47, 0.94). However, a higher risk of vascular complications (RR 11.72, 95% CI 3.75, 36.64), moderate or severe paravalvular leak (RR 5.04, 95% CI 3.01, 8.43), and permanent pacemaker implantations (RR 4.62, 95% CI 2.63, 8.12) was noted for TAVR. CONCLUSION Among lower risk patients, TAVR and SAVR appear to be comparable in short term outcomes. Additional high quality studies among patients classified as low risk are needed to further explore the feasibility of TAVR in all surgical risk patients.

Transcatheter Aortic Valve Replacement: Comprehensive Review and Present Status

Aortic stenosis is the most common valvular heart disease in the developed world. About 7% of the population over age 65 years suffers from degenerative aortic stenosis. The prognosis of patients with symptomatic severe aortic stenosis is dismal without valve replacement. Even though the American College of Cardiology recommends aortic valve replacement to treat this condition as a class I recommendation, approximately one third of these patients over the age of 75 years are not referred for surgery. Typically, this is from concern about prohibitive surgical risk associated with patient frailty, comorbidities, age, and severe left ventricular dysfunction. The advent in France of transcatheter aortic valve replacement has raised the hope in the United States for an alternative, less invasive treatment for aortic stenosis. Two recent trials-the Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve (Partner) and the CoreValve US Pivotal-have established transcatheter aortic valve replacement as the preferred approach in patients who are at high or prohibitive surgical risk. The more recently published Partner 2 trial has shown the feasibility of transcatheter aortic valve replacement in intermediate-surgical-risk patients as well. With a profile that promises easier use and better valve performance and delivery, newer-generation valves have shown their potential for further improvement in safety profile and overall outcomes. We review the history and status of this topic.

Early transcatheter valve prosthesis degeneration and future ramifications

Transcatheter aortic valve replacement (TAVR) has become the treatment of choice for patients with severe, symptomatic aortic stenosis with prohibitive risk for valve replacement surgery (SAVR) and is now considered a favourable alternative to surgical management for patients considered to be high risk (1). Recently published results of the PARTNER 2 trial have demonstrated that TAVR is an acceptable treatment option for patients with intermediate surgical risk and may hold an advantage over surgery if feasible via transfemoral approach (2). As we continue to explore the possibility of TAVR for lower risk patients who are typically younger and good candidates for surgical therapy, the durability of the prosthesis becomes an important consideration. Bioprosthetic valve failure after surgical aortic valve replacement (SAVR) is well described and well investigated. Structural valve deterioration is the most common noted cause with incidence of <1%, 10–30%, and 20–50% at 1, 10 and 15 years respectively (3,4). A recent report highlighting concerns regarding the long-term durability of the early SAPIEN prosthesis has certainly compelled the structural heart community to take a step back and better evaluate the future of TAVR for patients at low surgical risk (5). Currently, clinical trials are recruiting patients in the United States to examine the efficacy of TAVR in low risk patients, both studying the Medtronic CoreValve Evolut R System (NCT02701283) and the Edwards S3 system (PARTNER 3 trial, NCT02675114).

Staged High-Risk Percutaneous Coronary Intervention with Impella Support after On-Pump Transcatheter Aortic Valve Replacement

The management of concomitant obstructive coronary artery disease and severe aortic stenosis in poor surgical candidates is an evolving topic. Although the typical current practice is to perform percutaneous revascularization before transcatheter aortic valve replacement (TAVR), some data have emerged regarding revascularization after performing TAVR. We present the case of a 90-year-old man with multivessel coronary artery disease who was at prohibitive risk for surgical aortic valve replacement. We first performed TAVR with use of hemodynamic support, then Impella-assisted multivessel percutaneous coronary intervention on the patients unprotected left main coronary artery. We describe this complex case and review the medical literature on percutaneous coronary intervention after TAVR.

Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond

BACKGROUND Transcatheter aortic valve implantation/replacement (TAVI/TAVR) is becoming more frequently used to treat aortic stenosis (AS), with increasing push for the procedure in lower risk patients. Numerous randomized controlled trials have demonstrated that TAVI offers a suitable alternative to the current gold standard of surgical aortic valve replacement (SAVR) in terms of short-term outcomes. The present review evaluates long-term outcomes following TAVI procedures. METHODS Literature search using three electronic databases was performed up to June 2017. Studies which included 20 or more patients undergoing TAVI procedures, either as a stand-alone or concomitant procedure and with a follow-up of at least 5 years, were included in the present review. Literature search and data extraction were performed by two independent researchers. Digitized survival data were extracted from Kaplan-Meier curves in order to re-create the original patient data using an iterative algorithm and subsequently aggregated for analysis. RESULTS Thirty-one studies were included in the present analysis, with a total of 13,857 patients. Two studies were national registries, eight were multi-institutional collaborations and the remainder were institutional series. Overall, 45.7% of patients were male, with mean age of 81.5±7.0 years. Where reported, the mean Logistic EuroSCORE (LES) was 22.1±13.7 and the mean Society of Thoracic Surgeons (STS) score was 9.2±6.6. The pooled analysis found 30-day mortality, cerebrovascular accidents, acute kidney injury (AKI) and requirement for permanent pacemaker (PPM) implantation to be 8.4%, 2.8%, 14.4%, and 13.4%, respectively. Aggregated survival at 1-, 2-, 3-, 5- and 7-year were 83%, 75%, 65%, 48% and 28%, respectively. CONCLUSIONS The present systematic review identified acceptable long-term survival results for TAVI procedures in an elderly population. Extended follow-up is required to assess long-term outcomes following TAVI, particularly before its application is extended into wider population groups.

Meta‐analysis of transfemoral TAVR versus surgical aortic valve replacement

In the recently concluded PARTNER 2 trial, TF‐TAVR cohort was shown to have lower risks of death or disabling strokes as compared to SAVR, whereas the outcomes with transthoracic TAVR were comparable with SAVR.

Early versus late percutaneous revascularization in patients hospitalized with non ST-segment elevation myocardial infarction: The atherosclerosis risk in communities surveillance study.

Current guidelines recommend early invasive intervention (<24 hr) for high risk patients with non‐ST‐segment elevation myocardial infarction (NSTEMI). A delayed invasive strategy (24–72 hr) is considered reasonable for low risk patients. The real‐world effectiveness of this strategy is unknown.

Culprit versus multivessel coronary intervention in ST-segment elevation myocardial infarction: A meta-analysis of randomized trials

Background The 2015 American College of Cardiology/American Heart Association update on primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) recommended PCI of the non-infarct-related artery at the time of primary PCI (class IIb recommendation). Despite evidence supporting complete revascularization in STEMI, its benefit on mortality rates is uncertain. Methods We searched all available databases for randomized controlled trials comparing complete multivessel percutaneous coronary intervention (CMV PCI) with infarct-artery-only revascularization in patients with STEMI. Summary risk ratios and 95% confidence intervals (CIs) were calculated for both the efficacy and safety outcomes. Results Nine randomized controlled trials fulfilled the inclusion criteria, yielding 2991 patients. Follow-up periods ranged from 6 to 36 months. Compared with infarct-related artery-only PCI, CMV PCI was associated with significantly lower rates of major adverse cardiac events [relative risk (RR)=0.54, 95% CI=0.41–0.71; P<0.00001], cardiovascular mortality (RR=0.48, 95% CI=0.28–0.80; P=0.005), and repeat revascularization (RR=0.38, 95% CI=0.30–0.47; P<0.00001). Although, contrast-induced nephropathy and major bleed rates were comparable between both groups, CMV PCI failed to show any reduction in all-cause mortality (RR=0.75, 95% CI=0.53–1.07; P=0.11) and nonfatal myocardial infarction (RR=0.69, 95% CI=0.43–1.10; P=0.12). Conclusion Our results suggest that in patients with STEMI and multivessel disease, complete revascularization is safe, and is associated with reduced risks of major adverse cardiac events and cardiac death along with a reduced need for repeat revascularization. However, it showed no beneficial effect on all-cause mortality and nonfatal myocardial infarction.

Type 2 versus type 1 myocardial infarction: a comparison of clinical characteristics and outcomes with a meta-analysis of observational studies

BACKGROUND Type 2 myocardial infarction (MI) is an imbalance between myocardial oxygen demand and supply, leading to myocardial ischemia. It is not due to plaque rupture, and is usually caused by a condition other than coronary artery disease (CAD). However, limited data are available comparing the prevalence of traditional coronary risk factors and mortality between type 1 and type 2 MI. We hypothesize that type 2 MI carries a higher mortality than type 1. METHODS We searched the databases of PubMed, EMBASE, CENTRAL, and MEDLINE for studies comparing type 1 MI with type 2 MI. The baseline variables were compared in each cohort. Summary risk ratios and 95% confidence intervals were calculated using the random effects model to compare mortality between the two groups. RESULTS The included studies yielded 25,872 patients of whom 2,683 (10%) had type 2 MI. Compared to the type 1 cohort, the type 2 cohort had significantly higher inpatient (15% vs. 4.7%, P<0.00001), 30-day (17.6% vs. 5.3%, P<0.00001) and 1-yr mortality (27% vs. 13%, P<0.00001), as well as higher 30-day major adverse cardiovascular events (20% vs. 9%, P<0.0001). Operative stress (20%) was the most common trigger of type 2 MI, followed by sepsis (19%), arrhythmia (18.63%), heart failure (15%), and anemia (12%). CONCLUSIONS Type 2 MI is a common entity and is more common in females, older age groups, and in patients with multiple comorbidities: it also tends to result in higher mortality.