Transcatheter aortic valve replacement: The year in review 2017.

This article is a continuation of our previously published annual reviews of transcatheter aortic valve replacement (TAVR). In 2017, TAVR further established a foothold in the management of intermediate risk patients with the publication of SURTAVI trial. Randomized trials also addressed the use of cerebral protection during TAVR and single versus dual antiplatelet therapy after TAVR. Newer generation valve systems continued to be studied for their efficacy and safety. This paper summarizes the major studies published in 2017.

Transcatheter aortic valve replacement: The year in review 2016.

Transcatheter aortic valve replacement (TAVR) continued to make major strides in 2016, simultaneously expanding its application to lower risk patients as well as more technically challenging subsets of patients with aortic stenosis (AS). The two major accomplishments this year were the establishment of TAVR as the preferred treatment strategy over surgical aortic valve replacement (SAVR) in intermediate risk patients, and initial signals that TAVR and SAVR may be clinically equivalent in low-risk populations. Meanwhile, there is continued expansion of TAVR to challenging clinical subsets (bicuspid aortic valve [BAV], patients with concomitant advanced coronary artery disease [CAD], and failed surgical bioprostheses), and encouraging initial experiences with newer transcatheter heart valve systems. This paper summarizes the major research studies published on TAVR in 2016.

Transcatheter aortic valve replacement: game-changing innovation for patients with aortic stenosis.

Transcatheter aortic valve replacement (TAVR) is an emerging technology for the management of patients with severe aortic stenosis (AS). First reported in 2002, TAVR has made remarkable progress in the past decade with completion of major randomized clinical trials, multiple observational registries, and evolution of several new devices. This article is a brief introductory overview of the TAVR procedure, devices, trials and registries, and newer developments in the field.

Percutaneous Coronary Intervention: 2015 in Review.

In order to keep the interventional community up-to-date with the overwhelming amount of new data, we have selected where we believe to be the most important publications in percutaneous coronary intervention from January 1, 2015 to mid-November 2015. We hope that this will serve as an important overview of 2015, and ongoing reference for future years.

Transcatheter Aortic Valve Replacement: 2015 in Review.

Transcatheter aortic valve replacement (TAVR) has emerged as an attractive option for patients with severe symptomatic aortic stenosis (AS) who are either at high risk or extreme risk for surgical aortic valve replacement (SAVR). This article summarizes the major advances in TAVR that were published or reported in 2015.

Short-term outcomes of balloon angioplasty versus stent placement for patients undergoing primary percutaneous coronary intervention: Implications for patients requiring early coronary artery bypass surgery.

BACKGROUND: In patients with acute ST-elevation myocardial infarction (STEMI) needing early coronary artery bypass graft (CABG) surgery, it is unknown whether primary percutaneous balloon angioplasty (PTCA)-without stent implantation-allows safe transition to subsequent CABG. METHODS: We examined acute STEMI patients enrolled in the Stent-PAMI and CADILLAC trials to study the differences in the early clinical events between those treated with primary PTCA (n = 1494) or primary stenting (n = 1488). RESULTS: Baseline clinical and pre- and post-procedural angiographic features including post-intervention TIMI 3 flow rates were similar in the 2 groups with the exception of higher median infarct-artery residual stenosis in the PTCA group (26% [IQR 19%-34%] vs. 18% [IQR 11-25%], P < .001]. Provisional stenting was required in 16% of patients in PTCA group, while stents could not be implanted in 2% of the stent group. Sixty-percent of PTCA patients had stent-like balloon result. The rate of 30-day ischemia-driven target vessel revascularization was higher in the PTCA group (4.3% vs. 2.0%, P < .001 [4.6% vs 2.3%, P < .001 among patients with multivessel disease and 3.4% vs. 2.0%, P = .044 in patients with stent-like balloon results]) while 30-day major adverse cardiac events (6.2% vs 4.9%), death (1.8% versus 2.8%), and reinfarction (0.9% vs. 0.7%) were similar in the 2 groups. CONCLUSIONS: Compared with primary stenting, primary PTCA of infarct artery in STEMI patients was associated with significant increase in ischemia-driven target vessel revascularization (ITVR) rate, yet with no increased risk of major adverse cardiac events, reinfarction or death. Thus, provided close surveillance is maintained and prompt treatment initiated for early ischemic events, PTCA (particularly in those with stent-like balloon result) may be a reasonable and safe option in STEMI patients needing early CABG.

Drug-eluting stents versus bare-metal stents in patients with decreased GFR: a meta-analysis.

BACKGROUND: Decreased estimated glomerular filtration rate (eGFR) is a strong predictor of both mortality and subsequent cardiac events after percutaneous coronary intervention. The safety and efficacy of drug-eluting (DESs) versus bare-metal stents (BMSs) in this population have not been evaluated adequately. STUDY DESIGN: A systematic review and meta-analysis. SETTING & POPULATION: Studies involving the comparison of clinical outcomes between DESs and BMSs in patients with eGFR <60 mL/min/1.73 m(2). Studies exclusively involving patients with ST-segment elevation myocardial infarction were excluded. SELECTION CRITERIA FOR STUDIES: MEDLINE (on Ovid), EMBASE, and the Cochrane Library databases from 2002-2013 were searched for studies comparing DESs with BMSs in patients with eGFR <60 mL/min/1.73 m(2). INTERVENTION: DES versus BMS implantation. OUTCOMES: Mortality, repeat revascularization, myocardial infarction, and stent thrombosis. RESULTS: Data from 26 comparative studies with 66,840 patients were included. Compared with BMSs, DESs were associated with significant reductions in repeat revascularization (OR, 0.61; 95% CI, 0.50-0.74; P < 0.001) and myocardial infarction (OR, 0.85; 95% CI, 0.79-0.92; P < 0.001), with no detectable difference in stent thrombosis (OR, 0.72; 95% CI, 0.46-1.12; P = 0.1). The superiority of DESs over BMSs in decreasing mortality also was documented (OR, 0.77; 95% CI, 0.65-0.90; P = 0.01). This survival benefit of DESs over BMSs was attenuated in randomized controlled trials or adjusted observational studies versus unadjusted observational studies. LIMITATIONS: Most studies were observational studies. Meta-analysis was not performed on individual patient data. CONCLUSIONS: DES use in patients with eGFR <60 mL/min/1.73 m(2) is associated with a reduced rate of repeat revascularization and myocardial infarction without increased risk of stent thrombosis. The true effect of DESs versus BMSs on mortality needs to be confirmed by randomized controlled trials.

Variability in maximal suggested door-in-door-out time for hospitals transferring patients for primary angioplasty in STEMI.

OBJECTIVES: We derived a formula for maximal suggested door-in-door-out time (DIDO) for hospitals that do not perform primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). BACKGROUND: Efforts to minimize DIDO at non-PCI hospitals can improve door-to-balloon time (D2B). Targeting a maximal suggested DIDO for a transferring hospital can influence reperfusion strategy. METHODS: We examined time to treatment intervals for 193 STEMI patients who underwent primary PCI at our hospital. D2B in transferred patients (D2BT ) was divided into 3 intervals: transferring hospital DIDO, inter-hospital transport time, and interventional time. We defined maximal suggested DIDO as the maximum DIDO that would allow PCI with D2BT ≤ 120 minutes. RESULTS: D2B was higher in transfer compared to on-site patients (147 ± 52 vs. 75 ± 44 minutes, P < 0.0001). In transfer patients, treatment time intervals were: DIDO 80 ± 42 minutes, transport time 37 ± 18 minutes, interventional time 35 ± 16 minutes. The greatest variability in D2BT was related to DIDO. We estimated that maximal suggested DIDO = [120 - (transport time plus interventional time)]. Using a fixed interventional time of 40 minutes, we simplified this as: maximal DIDO = 80 - transport time. Maximal suggested DIDO for 4 transferring hospitals in our network ranged from 1 to 65 minutes. DIDO under the hospital-specific threshold was the strongest predictor of achieving D2BT <120 minutes. CONCLUSIONS: Transferring hospitals' maximal suggested DIDO is variable, and can be calculated from inter-hospital transport time. Instead of a universal target DIDO (e.g., <30 minutes), maximal suggested DIDO can be calculated individually for each non-PCI hospital within a STEMI network.

Everolimus-eluting stents versus sirolimus- or paclitaxel-eluting stents: two-year results from the Guthrie Health Off-Label Stent (GHOST) registry.

OBJECTIVES: We sought to compare the safety and effectiveness of everolimus-eluting stents (EES) versus first generation drug-eluting stents (FG-DES; sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]). METHODS: In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2-year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG-DES groups. Secondary end-points included all-cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end-points in 2 propensity-matched subgroups: EES versus SES; EES versus PES. RESULTS: Complete 2-year follow-up was available in 1,911 (90%) patients. Compared to FG-DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10-1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22-0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months. CONCLUSIONS: The use of EES compared to FG-DES appears to be associated with reductions in ST and TVR at 2-year follow-up. Improved outcomes with EES are observed in comparison with SES as well as PES.

Glycosylated hemoglobin and outcomes in diabetic patients with acute myocardial infarction after successful revascularization with stent placement: findings from the guthrie health off-label stent (GHOST) investigators.

OBJECTIVE: We evaluated the influence of glycemic control on cardiovascular outcomes in diabetic patients with acute myocardial infarction (AMI) who underwent successful percutaneous coronary intervention (PCI) with stent placement. BACKGROUND: In patients presenting with AMI, diabetic status confers adverse cardiovascular outcomes after PCI. However, the influence of glycemic control on outcomes after successful PCI is less well studied. METHODS: We examined 231 consecutive diabetes mellitus (DM) patients with AMI who underwent successful primary PCI and had evaluation of glycosylated hemoglobin (HbA1c) from 30 days before to 90 days after AMI. Patients were categorized in 2 groups, controlled DM with HbA1c ≤ 7.0 (N = 83, 36%) and uncontrolled DM with HbA1c > 7.0 (N = 148, 64%). We assessed 12-month cardiovascular outcomes in study groups. RESULTS: Uncontrolled diabetics were younger, tended to be less hypertensive, and had higher baseline glomerular filtration rate and final vessel diameter compared to controlled diabetics. Uncontrolled DM patients had similar major adverse cardiovascular events (MACE; composite of all-cause death, MI, target vessel revascularization [TVR], and stent thrombosis [ST]; 20% vs. 30%, log-rank P = 0.54), death (8.8% vs. 12%, P = 0.40), MI (8.8% vs. 9.6%, P = 0.76), TVR (9.5% vs. 8.4%, P = 0.95), and ST (3.4% vs. 4.8%, P = 0.54) as the controlled diabetics. In Cox regression analysis, after adjustment for baseline differences, glycemic control had no independent influence on study outcomes. CONCLUSION: Glycemic control, determined by HbA1c, does not seem to influence cardiovascular outcomes in diabetic patients with AMI after successful stent placement.

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents in ST elevation myocardial infarction: findings from the Guthrie Health Off-label Stent (GHOST) Registry.

BACKGROUND: Multiple randomized trials and observational studies have shown drug-eluting stents (DES) to be safe and effective at 3-year follow-up in stent thrombosis (ST)-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). However, outcomes data beyond 3-4 years after DES implantation are sparse. METHODS: We studied 554 STEMI patients who underwent successful PCI with either DES or bare metal stent (BMS). Primary study end-points were time to occurrence of ST and the composite of death or myocardial infarction (MI). Secondary end-points were time to occurrence of major adverse cardiac events (MACEs) and discrete events that comprise MACE (death, MI, and target vessel revascularization [TVR]). Outcomes of the DES and BMS groups were assessed by survival analysis and multivariable Cox regression. RESULTS: There were 205 (37%) patients who received DES and 349 (63%) patients who received BMS. At a median follow-up of 41.4 months after PCI, there were no differences in the unadjusted incidence of ST (ST, 3.4 vs. 4.3%, log-rank P = 0.61) and MI (6.8% vs. 8%, P = 0.61) between DES versus BMS groups, respectively. However, DES implantation was associated with lower unadjusted incidence of death or MI (11% vs. 23.5%, P = 0.0002), MACE (16% vs. 34%, P < 0.0001), death (6.3% vs. 17%, P = 0.0004), and TVR (9.8% vs. 18%, P = 0.008) than BMS implantation. In multivariable analyses, DES implantation was associated with significantly lower incidence of MACE (adjusted HR = 0.47 [95% CI: 0.31-0.76], P = 0.0007) than BMS implantation. CONCLUSION: In our study of STEMI patients, DES implantation was safer than BMS implantation and was associated with lower MACE at long-term follow-up.

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents following successful PCI in non-ST-elevation myocardial infarction: findings from the Guthrie Health Off-Label StenT (GHOST) Registry.

BACKGROUND: The long-term safety and effectiveness of drug-eluting stents (DES) versus bare metal stents (BMS) in non-ST-segment elevation myocardial infarction (NSTEMI) beyond 2 years after percutaneous coronary intervention (PCI) is unknown. METHODS: We studied 674 NSTEMI patients who underwent successful PCI with DES (n = 323) or BMS (n = 351). The primary study end-points were time to occurrence of death or nonfatal recurrent myocardial infarction (MI), and stent thrombosis (ST). Secondary end-points included time to occurrence of target vessel revascularization (TVR) and any major adverse cardiovascular event (MACE, defined as the composite of death, MI, ST, TVR). RESULTS: The DES and BMS groups were well matched except that DES patients received dual antiplatelet therapy for a longer duration and had smaller final vessel diameter. In survival analysis, at a mean follow-up of 1333 ± 659 days after PCI, the DES group had similar incidence of death/myocardial infarction (24% vs. 27%, log rank p = 0.23) and ST (4.0% vs. 2.6%, p = 0.18) as the BMS group. The DES patients had lower incidence of TVR (8.1% vs. 17%, p = 0.0018) but similar MACE (26% vs. 37%, p = 0.31). In multivariable analysis, DES vs. BMS implantation showed no significant impact on death/myocardial infarction [adjusted hazards ratio (HR) 1.0, 95% confidence intervals (CI) 0.7-1.4], ST (HR 1.7; CI 0.7 - 4.0), or MACE (HR 0.8; CI 0.6 - 1.1). However, TVR was lower in the DES group (HR 0.4; CI 0.3 - 0.7). CONCLUSION: In patients presenting with NSTEMI, DES implantation appears to be as safe as BMS implantation at long-term follow-up. In addition, DES are effective in reducing TVR compared to BMS.

Developing a new hybrid revascularization program: a road map for hospital managers and physician leaders.

Hybrid coronary revascularization, which involves minimally invasive direct coronary artery bypass surgery using the left internal mammary artery to left anterior descending and percutaneous coronary intervention using drug-eluting stents for the remaining diseased coronary vessels, is an innovative approach to decrease the morbidity of conventional surgery. Little information is available to guide hospital managers and physician leaders in implementing a hybrid revascularization program. In this article, we describe the people-process-technology issues that managers and leaders are likely to encounter as they develop a hybrid revascularization program in their practice.

Thrombocytopenia following percutaneous coronary intervention.

BACKGROUND: Thrombocytopenia following percutaneous coronary intervention (PCI) is an underappreciated condition that is often clinically challenging. There are no guidelines on the management of patients with this condition. OBJECTIVE: To review recent data in etiologies, risk factors, prevention, management, and prognostic implications of thrombocytopenia following PCI. EVIDENCE ACQUISITION: Search of MEDLINE, EMBASE, the Cochrane Database, and Google Scholar using the term thrombocytopenia + PCI and other relevant keywords to identify systematic reviews, clinical trials, cohort studies, case series, and case reports. The review was limited to English-language articles published between January 1980 and June 2009. Articles on patients with baseline thrombocytopenia prior to PCI were excluded. EVIDENCE SYNTHESIS: Thrombocytopenia is not infrequent following PCI. The typical patient with post-PCI thrombocytopenia is on multiple therapies that can potentially cause a decrease in the platelet count. Identification of the cause is critical because management of the condition varies significantly based on the etiology. The severity of the thrombocytopenia also determines the clinical management of the patient. Several observational studies have demonstrated the adverse prognostic impact of the complication on clinical outcomes and have identified risk factors. CONCLUSIONS: Judicious use of therapies that can cause thrombocytopenia, efficient detection of the cause of the decrease in platelet count, and appropriate management of the condition can potentially improve the quality of care and outcomes following PCI. Further research into risk factors that predispose post-PCI patients to developing thrombocytopenia is warranted.

Low-dose versus high-dose aspirin after percutaneous coronary intervention: analysis from the guthrie health off-label StenT (GHOST) registry.

BACKGROUND: The optimal dose of aspirin therapy after percutaneous coronary intervention (PCI) remains unclear. We sought to compare the effectiveness and safety of low and high doses of aspirin in preventing adverse outcomes after PCI. METHODS: We studied 2,820 consecutive patients who underwent coronary stenting for stable or unstable coronary artery disease (excluding cardiogenic shock) discharged alive without any complications between 2001 and 2007. Patients were categorized based on the discharge aspirin dose into low-dose (81 mg/day, N = 313) or high-dose (162-325 mg/day, N = 2,507) groups. The primary end-points (adjusted using Cox Proportional Hazard and propensity scores) were major adverse cardiovascular events (MACE; a composite of death, myocardial infarction [MI], stent thrombosis [ST], or target vessel revascularization) and net adverse clinical events (NACE; a composite of MACE and thrombolysis in myocardial infarction [TIMI][major or minor] bleeding) at 1 year. RESULTS: In the low-dose versus high-dose groups, MACE occurred in 8.6 versus 9.2% (log rank P = 0.71) and NACE in 11 versus 10% (log rank P = 0.58). In multivariable analysis, low-dose aspirin was not associated with worse outcomes (adjusted HR [95% CI] 0.74 [0.49-1.14] for MACE; 1.03 [0.71-1.50] for NACE). CONCLUSION: Low-dose aspirin, as prescribed in this study of routine practice, was not associated with worse outcomes compared to high-dose aspirin. (J Interven Cardiol 2011;24:307-314).

Hemodynamic support using the Impella 2.5 catheter system during high-risk percutaneous coronary intervention in a patient with severe aortic stenosis.

The Impella 2.5 catheter is a percutaneously implanted left ventricular assist device cleared by the Food and Drug Administration to provide circulatory support for up to 6 hours. The presence of aortic stenosis is deemed to be a contraindication to its use, and ongoing clinical trials exclude patients with an aortic valve area of 1.5 cm(2) or less. We describe a case of severe aortic stenosis with an estimated valve area of 0.9 cm(2) and severe ischemic cardiomyopathy in whom the Impella catheter was successfully used for high-risk multivessel percutaneous coronary intervention.

Efficiency, Safety, and Quality of Life After Transcatheter Aortic Valve Implantation Performed With Moderate Sedation Versus General Anesthesia.

There is growing interest in "minimalist" transcatheter aortic valve implantation (M-TAVI), performed with conscious sedation instead of general anesthesia (GA-TAVI). We assessed the impact of M-TAVI on procedural efficiency, long-term safety, and quality of life (QoL) in 477 patients with severe aortic stenosis (82 years, women 50%, STS 5.0), who underwent M-TAVI (n = 278) or GA-TAVI (n = 199). M-TAVI patients were less likely to have NYHA Class ≥3, valve-in-valve TAVI, and receive self-expanding valves. M-TAVI was completed without conversion to GA in 269 (97%) patients. M-TAVI was more efficient that GA-TAVI including shorter lengths of stay (2 vs 3 days, p <0.0001), higher likelihood of being discharged home (87% vs 72%, p <0.0001), less use of blood transfusions (10% vs 22%, p = 0.0008), inotropes (13% vs 32%, p <0.0001), contrast volume (50 vs 90 ml, p <0.0001), fluoroscopy time (20 vs 24 minute, p <0.0001), and need for >1 valves (0.4 vs 5.5%, p = 0.0004). At 1-month, death/stroke (M-TAVI vs GA-TAVI 4.0 vs 6.5%) and a "safety composite" end point (death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding, and new pacemaker: 17.6% vs 21.1%) were similar (p = NS for both). At a median follow-up of 365 days, survival curves showed similar incidence of death/stroke as well as the safety composite end point between the groups. QoL scores were similar at baseline and 1-month after TAVI. In multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency. In conclusion, M-TAVI is more efficient than GA-TAVI, with similar safety at 1-month and long-term, and similar QoL scores at 1 month.

Coronary and Structural Heart Disease Interventions During COVID-19 Pandemic: A Road Map for Clinicians and Health Care Delivery Systems.

BACKGROUND: Because of the COVID-19 pandemic, cath labs have had to modify their workflow for elective and urgent patients. METHODS: We surveyed 16 physicians across 3 hospitals in our healthcare system to address COVID-19 related concerns in the management of interventional and structural heart disease patients, and to formulate system wide criteria for deferring cases till after the pandemic. RESULTS: Our survey yielded common concerns centered on the need to protect patients, cath lab staff and physicians from unnecessary exposure to COVID-19; for COVID-19 testing prior to arrival to the cath lab; for clear communication between the referring physician and the interventionalist; but there was initial uncertainty among physicians regarding the optimal management of ST elevation myocardial infarction (STEMI; percutaneous coronary intervention versus thrombolytics). Patients with stable angina and hemodynamically stable acute coronary syndromes were deemed suitable for initial medical management, except when they had large ischemic burden. Most transcatheter aortic valve implantations (TAVI) were felt appropriate for postponement except in symptomatic patients with aortic valve area <0.5 cm2 or recent hospitalization for heart failure (HF). Most percutaneous mitral valve repair (pMVR) procedures were felt appropriate for postponement except in patients with HF. All left atrial appendage closure (LAAC) and patent foramen ovale (PFO)/atrial septal defect (ASD) closure procedures were felt appropriate for postponement. CONCLUSION: Our survey of an experienced team of clinicians yielded concise guidelines to direct the management of CAD and structural heart disease patients during the initial phases of the COVID-19 pandemic.