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COMPLEX PCI 2022

Guideline and concept changes: revascularization for Left Main in 2022

Percutaneous coronary intervention (PCI) may not lower mortality risk more than bypass surgery in left main (LM) – a leading interventional cardiologist said – but both are complementary strategies for achieving different clinical endpoints, making patient preference important. “Evidence generated so far makes it safe to say that PCI does not improve survival more than coronary artery bypass grafting (CABG) in patients with stable ischemic heart disease (SIHD),” Duk-Woo Park, MD, PhD (Asan Medical Center, Korea), said at COMPLEX PCI 2022 on Nov 24 at the Grand Walkerhill Seoul in South Korea. He presents evolving concepts and guideline recommendations on revascularization for LM disease at the COMPLEX PCI 2022 conference held at the Grand Walkerhill Seoul in South Korea on Nov 24. “However, PCI plays a key role in acute coronary syndrome (ACS), especially for improving patient-oriented outcomes of angina patients who are either unresponsive to medical therapy, unwilling to take anti-anginal medication or unwilling to undergo invasive CABG,” he said. Although tradition held CABG as the gold standard of treatment for a wide spectrum of SIHD patients, especially those with LM-coronary artery disease (CAD), technological and technical advancements in PCI and optimal medical therapy (OMT) spurred requests to replace “outdated” studies that cast PCI in an unfavorable light against OMT and CABG. As an interventional cardiologist, the evidence generated so far makes it safe to say that PCI does not improve survival more than CABG in SIHD. Both older and more recent studies on SIHD – including MASS II (2004), COURAGE (2007), BARI 2D (2009) and FAME-2 (2012) – had shown negative or neutral results with PCI compared to OMT for the “hard” clinical endpoints of all-cause or cardiovascular (CVD) mortality. Studies on multivessel disease (MVD) – including the SYNTAX (2019), BEST (2015), FREEDOM (2012) and FAME-3 (2022) trials – also found lower rates of major adverse cardiovascular events (MACE) with CABG compared to PCI. However, contemporary studies incorporating state-of-the-art PCI – including SYNTAX-LM (2010), PRECOMBAT (2011) and EXCEL (2016) – began demonstrating comparable outcomes between stenting and surgery, reporting no statistically significant difference between PCI and CABG for all-cause mortality and the primary endpoint. Studies on state-of-the-art PCI versus CABG in LM disease.Source: Dr. Park's slides at COMPLEX PCI 2022 Notably, the 10-year follow-up results for mortality from SYNTAX-LM(CABG 26.7% vs. PCI 26.1%; HR 0.90; 95% CI; 0.68-1.20; P=0.47) and AMC’s 10-year PRECOMBAT LM (CABG 13.8% vs. PCI 14.5%; HR 1.13; 95% CI; 0.75-1.70; P=0.57) further signaled comparability between strategies. The 5-year follow-up of the EXCEL trial, which reported comparable outcomes between bypass surgery and PCI for major adverse cardiac and cerebrovascular events (MACCE), infamously came under fire for controversial interpretations of outcomes and fueled the debate between cardiac surgeons and interventionalists. Along with significant study limitations of the EXCEL trial – including underpowered outcomes (“prone to false negatives”), no adjustment for multiplicity (“prone to false positives”) and no P-values (“not designed for hypothesis testing”) –other contemporary studies, like the REVIVED-BCIS2 study also found no survival benefit with PCI over OMT, raising calls for more concrete data. PCI plays a key role in ACS by improving patient-oriented outcomes of angina patients who are either unresponsive to medical therapy, unwilling to take anti-anginal medication or unwilling to undergo invasive CABG. Interventional cardiologists tended to call for new randomized trials with “different patients, better stents, more IVUS or FFR, more follow-up or other trial endpoints” any time a new series of trials reported neutral or worse outcomes with PCI compared to OMT or CABG, he explained, despite the lack of mortality benefit with PCI: “The higher benefit of survival with CABG over PCI was a key issue in many (observational) studies like EXCEL and urged individual patient data (IPD) meta-analysis.” The highly anticipated meta-analysis – published in the Lancet last year by Marc S. Sabatine, MD (Brigham and Women's Hospital, Boston, USA) and investigators, including ones at AMC – found no significant difference in all-cause mortality between treatment arms (PCI 11.2% vs. CABG 10.2%; HR 1.10; 0.91-1.32; P=0.33), indicating a statistically non-significant absolute difference of 0.9% (-0.9-2.8). Outcomes of the meta-analysis, which encompassed the four major trials of SYNTAX Left Main, PRECOMBAT, NOBLE and EXCEL, also found no significant difference between PCI and CABG arms after adjusting for SYNTAX scores (HR 1.09; 0.91-1.31). Separate analysis of the SYNTAX and PRECOMBAT studies, both with follow-up to 10-years, demonstrated no significant between-group differences for the endpoint of all-cause mortality (CABG 22.1% vs. PCI 21.6%; HR 0.96; 0.76-1.21; P=0.72). The major finding, he said, was no difference for the primary outcome of all-cause mortality between PCI and CABG for LM patients at intermediate- or low-anatomic risk but each approach had tradeoffs: CABG with higher risks for stroke (CABG 3.1% vs. PCI 2.7%; HR 0.84; 0.59-1.21; P=0.36) and procedural MI (4.7% vs. 3.2%; HR 0.67; 0.48-0.93; P=0.015); PCI had higher rates of spontaneous MI (2.6% vs. 6.2%; HR 2.36; 1.71-3.23; P

December 15, 2022 8869
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COMPLEX PCI 2022

[Expert Insight] Choosing guidewires for antegrade, retrograde approaches during CTO-PCI

Rapid development and advancement of chronic total occlusion (CTO)-dedicated guidewires and techniques, like the parallel wire technique, are increasing success rates of complex procedures during percutaneous coronary interventions (PCI), an expert said recently. “CTO guidewire development has been dramatically fast and innovative,” said Toshiya Muramatsu, MD (Tokyo Heart Center, Japan), during a remote presentation at COMPLEX PCI 2022 on Nov 25 at the Grand Walkerhill Seoul in South Korea. “Recently, the retrograde approach for CTO-PCIs has significantly impacted cases where the antegrade approach had failed,” he said. “New techniques and strategies that incorporate the retrograde approach have also advanced CTO-PCIs worldwide.” CTO, a condition that indicates complete or near complete blockage of one or more coronary arteries, is common in patients with ischemic heart disease. The complexity required to cross the CTO lesion has been associated with worse prognosis and procedural success rates compared to interventions for standard coronary lesions. Despite the more intricate challenge of CTO-PCIs, advances in device technology and procedural strategies have dramatically increased procedural success rates in recent years. The most common method of CTO intervention is the antegrade approach (AW), which crosses a guidewire in the direction of natural blood flow. AW is commonly used for less complex cases, like for coronary lesions with clear, tapered proximal cap and short (

December 01, 2022 6586
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COMPLEX PCI 2022

Evidence ‘reconciles’ 2 apparently different revasc procedures – PCI and CABG – for LM...

Recently published meta-analyses are laying the groundwork for “evidence-based reconciliation” between cardiac surgeons and interventionalists, an expert said, when determining an optimal revascularization strategy for patients with coronary artery disease (CAD). The longstanding and tortuous contention over whether percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery is the best treatment for patients with left main (LM)-CAD or multivessel (MV)-CAD has spurred several conflicting studies, both randomized and non-randomized, and heated debates over the years. Gregg W. Stone, MD (Icahn School of Medicine at Mount Sinai, USA), discusses PCI and CABG as treatment options for patients with LMCAD and MVCAD at COMPLEX PCI 2022 held at the GrandWalkerhill Seoul in South Korea on Nov 25. Experts are now mending the rift with conclusions of PCI and CABG being different, but complementary, procedures that produce relatively similar outcomes for the major endpoints of all-cause mortality, stroke and repeat revascularization, but each with notable tradeoffs. “Patients are smart, and they know the difference between the revascularization options for extensive CAD,” he said at COMPLEX PCI 2022 held at the Grand Walkerhill Seoul in South Korea on Nov 25. “Surgery is an incredible procedure but the recovery time is not insignificant, leading to most patients preferring PCI over CABG.” “For many patients with LMCAD, all specialists agree on the choice between PCI and CABG,” he said. ”CABG is often preferred for patients with extensive non-LM-related CAD and high SYNTAX scores while PCI is preferred for patients with multiple comorbidities such as prior stroke, lung disease or frailty.” “When clinical equipoise is present and either strategy can be done safely, both PCI and CABG provide substantial and comparable long-term improvements in survival and quality-of-life (QoL),” he said. “During the decision-making process, the heart team should consider the patient’s preferences regarding the early versus late trade-offs of each strategy.” PCI, known as the “less invasive” stenting procedure, is associated with fewer peri-procedural complications such as stroke, large myocardial infarction (MI), atrial fibrillation, bleeding and acute kidney injury, among others, compared to CABG. Studies have also shown more rapid recovery and higher QoL early on after PCI compared to surgery. Open-heart CABG surgery is more “durable” than PCI and has advantages like a lower risk of long-term adverse events after the procedure, especially for the outcomes of MI and repeat revascularization. The key question, he said, is to identify which patients benefit exceedingly with CABG to warrant a strong recommendation for surgery over PCI, since the former entails considerable physical discomfort and prolonged recovery. Recent meta-analysis published by Marc S. Sabatine, MD (Brigham and Women's Hospital, Boston, USA) and colleagues in the Lancet last year, found no significant difference between PCI and CABG for the primary endpoint of 5-year all-cause mortality (PCI 11.2% vs. CABG 10.2%, HR 1.10, 95% CI, 0.91-1.32, p=0.33), concluding that the benefits and risks of the procedures should be weighed for each patient. The meta-analysis, which compiled data from 4 major randomized trials on PCI with drug-eluting stents (DES) and CABG in 4,394 LMCAD patients also found no significant difference between arms for prespecified subgroups (age, sex, diabetes status, LVEF, number of diseased vessels and SYNTAX scores, among others). A significant difference favored CABG only for “very complex” LMCAD patients with SYNTAX scores over 45, he said. Regarding stroke risk – a factor that “may be more important than mortality for some” – analysis indicated a 1% absolute difference favoring CABG during the periprocedural period for up to 1-year, indicating that the risk of stroke should be weighed against the risk of mortality for LM patients. However, the difference in stroke risk was driven by a markedly higher rate of late (>1-year) strokes in patients treated with PCI in the NOBLE trial, he said, especially considering none of the other 3 trials or any prior trial on PCI versus CABG showed a higher stroke risk in the LMCAD group. For MVCAD patients, who have higher rates of diffuse, complex coronary disease than patients with LMCAD, balancing the tradeoff in mortality and stroke with patient preferences is also crucial. Pooled analysis of individual patient data published in 2018 by Stuart J. Head, MD (Erasmus University Medical Center, Rotterdam, Netherlands) and investigators in the Lancet previously showed a higher 5-year mortality rate with PCI than CABG (2.6% absolute difference; PCI 11.5% vs. CABG 8.9%; HR 1.28; 95% CI; 1.09-1.49; P=0002) – or about 0.5% per year – although most of the difference was driven by diabetic (n=3,266) and non-diabetic (n=3,774) subgroups. Data on MVCAD patients with diabetes that included 8 randomized trials on 7,040 patients from the original pooled analysis showed that although the diabetic subgroup had a higher risk of 5-year mortality with PCI over CABG (PCI 15.5% vs. CABG 10.0%; HR 1.48; 1.19-1.84; P=0.0004), they also had a significantly lower risk of 5-year stroke with PCI (PCI 2.6% vs. CABG 3.6%; HR 0.74; 95% CI; 0.56-0.99; P=0.039). The non-diabetic MVCAD group had comparable rates for 5-year mortality between PCI and CABG (PCI 8.7% vs. CABG 8.0%) and 5-year stroke risk (PCI 2.6% vs. CABG 2.4%; P=0.004). “Mortality risk should be offset with the risk of stroke, which was around 1% higher with CABG compared to PCI (3.6% vs. 2.6) for MVCAD patients with diabetes,” he said. “For the non-diabetic patient group, it seems like a good tradeoff; meanwhile, diabetic patients should be informed of the competing risks.” “Discussion other outcomes – including procedural MI, non-procedural MI, dyspnea and fatigue, infections, arrhythmias, renal dysfunction, chest pain, repeat revascularization, cognitive decline, and depression, among others – could go on for hours but the bottom line is that patients want to live longer, and live better,” he said. “Anything other than mortality is encapsulated in the QoL metric that includes all non-fatal outcomes.” 2 independent sub-studies on QoL outcomes from 2017 based on the SYNTAX (n=1,800) and EXCEL (n=1,905) trials, respectively, showed no major differences between PCI and CABG. “The SYNTAX sub-study showed no major differences in QoL and the only difference came from the Seattle Angina Questionnaire’s (SAQ) physical limitation score. Scores were much better with PCI in the first month but CABG caught up later,” he said. “Aside from some small differences, major late benefits were observed with both procedures.” “The EXCEL sub-study also showed similar QoL outcomes beyond 12 months but researchers found better outcomes with PCI in the first month. Again, CABG caught up to PCI between the 1-month and 1-year period,” he added. “And this is what patients know – it takes about 6 months to recover from physical and mental changes after CABG, but both PCI and CABG are excellent for relieving angina.” In a joint perspective article published in the European Heart Journal in April, Mario Gaudino, MD (Cornell Medicine, USA), Michael E. Farkouh, MD (University of Toronto, Canada) and he concluded that PCI and CABG are different procedures with unique early and late advantages. The procedures were similar when it came to the major outcomes of long-term survival and major adverse cardiovascular events (MACE) composite of death, large MI or stroke, they said, which helps “reconcile all outcomes.” “Studies have shown no major differences for the important outcomes of long-term survival, MACE and QoL,” he said. “The goal of the heart team is not to choose a procedure for the surgeon or interventionalist but to inform patients of the early versus late tradeoffs so they can choose a strategy that reflects their goals.”

December 01, 2022 8315
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SummitMD

TAVI noninferior to surgery for elderly, severe AS patients at moderate operative risk: UK TAVI

Transcatheter aortic valve implantation (TAVI) was noninferior to surgery, a United Kingdom (UK) study found recently, for elderly patients with severe, symptomatic aortic stenosis (AS) at moderately increased operative risk. The randomized clinical trial titled UK TAVI – published in the Journal of American Medical Association (JAMA) on May 17 by investigators – found 1-year all-cause mortality rates with TAVI were comparable to surgical aortic valve replacement (SAVR). TAVI – an alternative treatment to surgery with SAVR also known as transcatheter aortic valve replacement (TAVR) – is approved for symptomatic AS patients at high operative risk. The relatively minimally invasive stenting procedure also started gaining approval for AS patients at lower operative risk, although the benefits of TAVI in such groups are largely uncertain. UK TAVI was conducted at 34 centers in the UK and enrolled 913 patients with severe, symptomatic AS over 70 years of age at moderately increased operative risk (median age: 81 years; 46% female; median STS mortality risk score: 2.6%) to determine whether TAVI outcomes were comparable to SAVRs. 458 patients were randomized to a TAVI treatment group that allowed any approved valve in the UK along with all access routes and 455 patients were randomized to SAVR. Analysis showed the balloon-expandable SAPIEN 3 valve (Edwards Lifesciences; California; US) accounted for most operations (57%), followed by the self-expanding Evolut R valve (Medtronic; Minnesota, US) at 16%. Transfemoral access was most common for the TAVI arm (96%). Nearly all SAVR patients received a xenograft bioprosthesis. It is reassuring that UK TAVI – conducted with multiple valve types – confirmed major findings from previous RCTs that were limited to specific TAVI valves. Catherine M. Otto, MD, PhD & Jae-Kwan Song, MD Follow-up continued to April 2019 for the primary endpoint of all-cause mortality and 36 secondary outcomes at 1-year. The noninferiority margin was prespecified to 5% (upper limit of 1-sided 97.5% CI). At 1 year, results showed noninferiority for all-cause mortality between TAVI and SAVR (21 vs. 30 deaths; 4.6% vs. 6.6%; adjusted AR difference -2.0%, 1-sided 97.5% CI, −∞ to 1.2%; P

October 14, 2022 6185
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SummitMD

Recap: Takeaways from 2021 ACC/AHA/SCAI guideline for coronary artery revascularization

The 2021 American guidelines on coronary artery revascularization, reflecting new evidence from the evolving field, updated key recommendations on coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for a wide spectrum of heart patients. The updated 109-page guideline – drafted by an interdisciplinary 22-member writing committee – was jointly published by the American College of Cardiology (ACC), American Heart Association (AHA), and Society for Cardiovascular Angiography and Interventions (SCAI) in Circulation last year on Dec 9. Advocated foremost were the concepts of multidisciplinary heart teams to foster communication between clinicians and consistent treatment strategies for patients based on clinical indications, not race or gender, especially when the optimal strategy is debatable. “For patients where the optimal coronary revascularization strategy is unclear, a multidisciplinary Heart Team approach is recommended,” the writing committee wrote. “Treatment decisions should be patient-centered, incorporate patient preferences and goals and include shared decision-making.” “Revascularization decisions in patients with diabetes and multivessel coronary artery disease (CAD) are optimized by the Heart Team approach. Patients with diabetes and triple-vessel disease should undergo surgical revascularization; PCI may be considered if they are poor candidates for surgery.” The updated recommendations replace those of seven prior guidelines including the 2011 ACCF/AHA guideline for CABG; 2011 and 2015 ACCF/AHA/SCAI guidelines for PCI; 2012 ACCF/AHA/ACP guideline for stable ischemic heart disease; 2013 ACCF/AHA guideline for ST-segment elevation myocardial infarction (STEMI); 2014 AHA/ACC guideline for non-STEMI acute coronary syndrome (NSTEMI-ACS); and 2015 ACC/AHA/SCAI focused update on PCI in STEMI patients. Takeaways from the 2021 ACC/AHA/SCAI coronary artery revascularization guideline Coronary revascularization decisions for CAD patients should be based on clinical indications, not sex, race, or ethnicity (Class of Recommendation (COR) 1; Level of Evidence (LoE) B-NR) A multidisciplinary Heart Team approach (COR 1; LOE B-NR) and patient-centered treatment decisions (COR 1; C-LD) are recommended for potential revascularization where the optimal strategy is unclear. For SIHD with significant LMCAD, CABG is indicated to improve survival over medical therapy (COR 1; B-R). PCI is a reasonable option for improving survival over medical therapy in select CAD patients with low-to-medium anatomic complexity who are equally suitable for both CABG and PCI (COR 2a; B-NR). For SIHD patients with normal LVEF and triple-vessel CAD (with or without proximal LAD), CABG may be reasonable to improve survival (COR 2B; B-R) and usefulness of PCI to improve survival is uncertain (COR 2b; B-R). Radial artery for CABG is preferred over the saphenous vein to graft the second most important, significantly stenosed, non-LAD vessel for improving long-term cardiac outcomes (COR 1; B-R). IMA (preferably the left) should be used to bypass the LAD when bypass of the LAD is indicated to improve survival and reduce recurrent ischemic events (COR 1; B-NR). Bilateral IMA (BIMA) grafting by experienced operators can be beneficial in appropriate patients for CABG to improve long-term outcomes (COR 2a; B-NR). Radial artery access over the femoral approach is recommended for PCI in SIHD/ACS patients to reduce bleeding and vascular complications (COR 1; A). ACS patients derive mortality benefits with radial access. For PCI in select SIHD patients, a shorter DAPT duration (1- to 3-months) with subsequent transition to P2Y12 monotherapy is reasonable to reduce bleeding risk (COR 2a; A). Staged PCI of significant non-infarct artery stenosis is recommended for select hemodynamically stable STEMI and multivessel disease patients after successful primary PCI to reduce mortality/MI risk (COR 1; A). PCI of non-infarct artery stenosis may be considered at the time of primary PCI for select hemodynamically stable STEMI patients with low complexity multivessel disease to reduce cardiac event rates (COR 2b; B-R). Routing PCI of a non-infarct artery at the time of primary PCI should not be performed in STEMI patients with cardiogenic shock complications due to a higher risk of mortality or renal failure (COR 3; B-R). Fractional flow reserve (FFR) or instantaneous wave-free ratio (IFR) is recommended to guide PCI decisions for angina/anginal equivalent, undocumented ischemia, and angiographically intermediate stenosis (COR 1; A) but not for stable patients with angiographically intermediate stenoses (FFR>0.80 or IFR>0.89) (COR 3; B-R). In patients with intermediate stenosis of the LM artery, intravascular ultrasound (IVUS) is reasonable to help define lesion severity (COR 2a; B-NR). The STS score should be utilized for CABG (COR: 1; B-NR). The usefulness of the SYNTAX score is less clear because of interobserver variability/absence of clinical variables (COR: 2b; B-NR). Source: 2021 ACC/AHA/SCAI guidelines on coronary artery revascularization New and updated strategies recommended for revascularization, imaging, DAPT, risk scores Among key updates, the 2021 ACC/AHA/SCAI guidelines on coronary artery revascularization featured revised recommendations on coronary revascularization, imaging strategies, post-revasc medical therapies and risk scores. For coronary revascularization, recommendations were divided by disease groups that included STEMI (of both infarct and non-infarct arteries), NSTE-ACS, stable ischemic heart disease (SIHD), complex disease, and special populations like pregnant, older or chronic kidney disease (CKD) patients. For patients where the optimal coronary revascularization strategy is unclear, a multidisciplinary Heart Team approach is recommended. Major recommendations for SIHD were further divided into groups like multivessel coronary artery disease (MVCAD); left ventricular (LV) dysfunction and MVCAD; left main CAD (LMCAD); stenosis in the proximal LAD artery; and 1- or 2-vessel disease not involving the proximal LAD. For SIHD patients with significant LM stenosis, surgery with CABG was recommended over optimal medical therapy (OMT) to improve survival (COR 1; B-R). In the same patient group, PCI was recommended as a reasonable strategy to improve survival when it could provide outcomes comparable to CABG (COR 2a; B-NR). For SIHD patients with MVCAD and severe LV systolic dysfunction (LVEF < 35%), CABG was strongly recommended to improve mortality outcomes (COR 1; B-R). CABG was deemed reasonable (Class 2a) for select SIHD patients with MVCAD and mild-to-moderate LV dysfunction (LVEF 35-50%). For SIHD patients with triple-vessel disease, normal ejection fraction (EF) and significant stenosis in 3 major coronary arteries (with or without proximal LAD), CABG was recommended as a reasonable strategy to improve survival if the patient had anatomy favorable for surgery (COR 2b; B-R). For the same 3-vessel patient group, the usefulness of PCI to improve survival was “uncertain” but obtained an endorsement equal to CABG (COR 2b; B-R). Coronary revascularization with either strategy could be considered to treat significant stenosis of the proximal LAD artery in SIHD patients with normal LVEF (Class 2b; B-R). Both PCI and CABG were not recommended in SIHD patients with normal LVEF and 1- or 2-vessel CAD not involving proximal LAD (Class 3; B-R) or when 1 or more coronary arteries are anatomically or functionally insignificant (>70% diameter of non-LM coronary artery stenosis; FFR > 0.80) (Class 3; B-NR). Treatment decisions should be patient-centered, incorporate patient preferences and goals and include shared decision-making. On novel recommendations for PCI, the guideline endorsed staged PCI for significantly stenosed nonculprit arteries in select hemodynamically stable STEMI and multivessel disease patients to improve survival and MI outcomes (COR 1; A). PCI of the nonculprit artery at the time of intervention was deemed “less clear” but considerable at the time of primary PCI in select stable STEMI patients when uncomplicated revascularization of the culprit artery, low-complexity nonculprit disease and normal renal function are present (COR 2b; B-R). Routing PCI of the nonculprit artery at the time of primary PCI was contraindicated for STEMI patients with cardiogenic shock (COR 3; B-R). On imaging strategies, fractional flow reserve (FFR) and instantaneous wave-free ratio (IFR) were strongly recommended (COR 1; A) for patients with angina, undocumented ischemia and angiographically intermediate stenosis. Both FFR and IFR were contraindicated (COR 3; B-R) in stable patients with angiographically intermediate stenoses (FFR >0.80; IFR >0.89). For post-PCI maintenance therapy, a shorter period of dual antiplatelet therapy (DAPT) was deemed reasonable to reduce bleeding risk in SIHD patients (COR 2a; A). Shorter DAPT entailed 1- to 3- months of DAPT followed by discontinuing aspirin and resuming P2Y12 inhibitor monotherapy. On access routes, radial access was strongly recommended over femoral access for both CABG (COR 1; B-R) and PCI (COR 1; A) to reduce bleeding and vascular complications. For CABG, Class 1 recommendations were given to both radial access (B-R) and internal mammary artery (IMA) grafting (B-NR). Bilateral internal mammary artery (BIMA) received a Class 2a recommendation (B-NR). On risk scores to guide treatment decisions, the Society of Thoracic Surgeons (STS) score received a strong Class 1 recommendation (B-NR) while the SYNTAX score obtained a weaker Class 2b recommendation (B-NR) due to uncertainty of usefulness. SIHD revasc recommendations spark initial controversy, result in eventual consensus Of recommendations for SIHD patients, those on triple-vessel CAD incited heavy criticism from cardiac surgeons last year, causing a rift between medical specialties that panned out to an agreement that PCI and CABG are complementary, not antagonistic, strategies. Ultimately, PCI and CABG are two complementary interventions performed for different patients and different aims. Mario F.L. Gaudino, MD Starting with the American Association for Thoracic Surgery (AATS) and Society of Thoracic Surgeons (STS) on Dec 23, major surgical societies from the US, Europe, Latin America and Argentina, India, and Japan objected to the American guidance in respective letters published in international medical journals. Most protested were the recommendations on coronary revascularization compared to medical therapy that seemed to favor PCI over CABG for SIHD patients without sufficient evidence. Key points of opposition, stated by the AATS/STS and other surgical communities, included problems with the ISCHEMIA trial that was used as primary evidence to support stronger recommendations for PCI and weaker ones for CABG. Key points of opposition regarding the ISCHEMIA trial to support COR downgrades for CABG Not designed or powered to determine the survival outcome benefits of CABG - CABG accounted for only 26% of all revascularization; only 20% of the invasive strategy arm received CABG Enrolled a largely ineligible patient group; short follow-up of 3.2 years More patients in the invasive arm received optimal medical therapy than the CABG arm (21% vs. 20%) More patients in the initial conservative strategy got invasive revascularization (544 vs. 530) Heart Team approach was underutilized and resulted in significant underuse of CABG Despite study limitations, ISCHEMIA still showed favorable trends for the invasive arm Source: The American Association for Thoracic Surgery and The Society of Thoracic Surgeons Reasoning for Not Endorsing the 2021 ACC/AHA/SCAI Coronary Revascularization Guidelines Surgeons pointed out in respective publications that well-known randomized controlled trials (RCTs) like SYNTAX, EXCEL and NOBLE “clearly demonstrated” the superiority of CABG over PCI for repeat reinterventions and post-procedural MI that were not reflected in the guidelines. At TCTAP 2022, cardiac surgeon S. Christopher Malaisrie, MD (Northwestern University Feinberg School of Medicine, Illinois, USA) reemphasized the survival benefits of CABG for patients with MVD and LMCAD despite the recent CABG downgrades. “Evidence demonstrates survival benefits with CABG over OMT in multivessel disease and even more in LMCAD,” Malaisrie said. “But American and European clinical practice guidelines interpreted data differently, appearing to undervalue the benefits of CABG, and surgical associations have not endorsed their respective continental guidelines that discount ‘old’ data and undervalue new surgical techniques.” The committee considered various factors like studies of the ‘OMT era’ that show no survival benefit with CABG or revascularization compared to OMT. Sripal Bangalore, MD Addressing the controversy, interventional cardiologist Sripal Bangalore, MD (New York University School of Medicine, New York, USA) – who served on the 2021 ACC/AHA guideline writing committee – explained at TCTAP 2022: “The recommendations on triple-vessel disease generated the controversy, and the notion was that the guideline committee simply downgraded CABG recommendations.” “But the committee considered various factors like recent studies that showed no survival benefit with revascularization compared to OMT,” Bangalore said. “There was a clear benefit with CABG in triple-vessel disease at 6-months when comparing surgery to no surgery in the 1980s, but fast forward to the BARI 2D trial in 2009 and results showed – on purely the mortality endpoint for CABG, not PCI – no difference between CABG and medical therapy.” “Recent SIHD studies on revascularization also show no improvement in cardiac death with revascularization compared to OMT; however, we’re not saying do not revascularize for triple-vessel disease,” he said. “There are other benefits like preventing CV events including spontaneous MI and improving QoL for symptomatic patients.” In a separate session, Bangalore further stressed guideline-directed medical therapy (GDMT) as the “backbone” of all treatment: “One of the biggest problems today is people painting broad strokes of CABG and revascularization as superior to OMT based on the composite endpoint without looking at individual endpoints. RCTs results from the OMT era on the mortality endpoint send a consistent message.” One of the biggest problems today is that people paint broad strokes of revascularization being superior to OMT without looking at individual endpoints. Bangalore, MD Also a member of the guideline writing committee, cardiac surgeon Mario F.L. Gaudino, MD (Weill Cornell Medical College, Cornell University, New York, USA) said at TCTAP 2022: “We are essentially comparing two different interventions.” “Surgery has consistently shown similar mortality and reduced risk of MI and repeat revascularization for patients with MVD and LM disease amenable by either strategy,” Gaudino said. “PCI demonstrated comparable results to surgery for the first two years as a less invasive strategy.” “A difference favoring surgery is evident for patients with diabetes and complex disease as well as long-term clinical outcomes; however, CABG is associated with higher periprocedural risk and longer recovery rates,” he said. “Exempting the relative risk, the absolute difference between the two is small, which becomes evident in long-term follow-up. Ultimately, PCI and CABG are two complementary interventions performed for different patients and different aims.”

September 29, 2022 5310
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SummitMD

No difference between PCI-OMT for mortality, HF-hospitalization in severe LV dysfunction: REVIVED-BC...

Percutaneous coronary intervention (PCI) did not lower rates of all-cause mortality or heart failure (HF)-related hospitalization compared to optimized medical therapy (OMT) in patients with extensive coronary artery disease (CAD), a UK-based study found. The unblinded randomized comparative effectiveness REVIVED-BCIS2 trial on 700 patients (median age: 70 years; 88% male; 41% diabetes) with severe ischemic left ventricular (LV) systolic dysfunction reported no significant difference between PCI plus OMT versus OMT alone for the primary composite outcomes at 2-years (PCI 37.2% vs. OMT-alone 38.0%; HR 0.99, 95% CI, 0.75-1.27; P=0.96). Divaka Perera, MD presents REVIVED-BCIS2 results at ESC Congress 2022 in Barcelona, Spain on Aug 27.Picture source: ESC Congress 2022 Led by Divaka Perera, MD (King’s College London, London, UK), investigators also found no significant between-group differences in LV ejection fraction (LVEF) markers at 6-months and 12-months or quality-of-life outcomes based on the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) indices. REVIVED-BCIS2 is the first adequately powered RCT in the arena that showed PCI did not reduce all-cause death or HF-hospitalization. Divaka Perera, MD “Patients with ischemic cardiomyopathy continue to have high rates of mortality and hospitalization for HF, even with contemporary medical and device therapy,” Perera said at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, Spain on Aug 27. Results were published simultaneously in the New England Journal of Medicine (NEJM). “Although PCI was regarded as an attractive alternative to coronary artery bypass graft (CABG) to decrease surgical harm while delivering similar benefits for CAD patients, no randomized evidence exists to date,” Perera said. “REVIVED-BCIS2 is the first adequately powered randomized clinical trial (RCT) in the arena that showed PCI did not reduce the incidence of all-cause death or hospitalization for HF at a median of 3.4 years (85% power to detect 30% reduction with PCI and OMT).” “We can conclude that PCI should not be offered to stable patients with ischemic LV dysfunction if the sole aim is to provide prognostic benefit,” he added. REVIVED-BCIS2 Investigators set out to examine whether PCI plus OMT could outperform OMT-alone by randomizing 700 patients across 40 centers in the UK to treatment with PCI plus OMT (n=347; primary outcome available in 98.8%) or OMT-alone (n=353; primary outcome available in 99.4%) for at least 2-years. More than anything, this trial supports GDMT to manage LV dysfunction, irrespective of whether revascularization is considered Ajay J. Kirtane, MD Patient inclusion criteria were LVEF ≤35% (mean LVEF 28%); extensive CAD defined by a British Cardiovascular Intervention Society (BCIS)-Jeopardy Score ≥6; or viability myocardium in 4 or more segments feasible to revascularization with PCI. Exclusion criteria included acute myocardial infarction (MI) less than 4 weeks prior, acute decompensated HF or sustained ventricular arrhythmias. OMT, also known as guideline-directed medical therapy (GDMT), was defined as individually adjusted pharmacologic and device therapy for HF. The composite primary outcome was defined as all-cause mortality or HF-related hospitalization for a minimum of 24-months post-enrollment. Secondary outcomes included LVEF at 6- and 12-months and QoL at 6-, 12- and 24-months (measured by KCCQ, EQ-5D-5L and NYHA Functional Classification). During follow-up (median 3.4 years), investigators found no statistically significant difference between PCI and GDMT-alone for the primary composite outcome (PCI 37.2% vs. GDMT-alone 38.0%; 129 events vs. 134 events; HR 0.99, 0.75-1.27; P=0.96). Investigators reported at least one hospitalization (HR 0.97; 0.66-1.43) in the PCI (14.7%) and GDMT-alone arms (15.3%). Deaths occurred in 31.7% of the PCI group and 32.6% of the GDMT group (HR 0.98; 0.75-1.27). We’ve learned that medical therapy works – and it’s getting better – but ischemic cardiomyopathy patients still have an unacceptably high mortality rate. Eric J. Velazquez, MD There were no significant differences for both the major secondary outcomes of LVEF at 6-months (difference -1.6%, -3.7%-0.5%) and 12-months (difference 0.9%, -1.7%-3.4%) or of quality-of-life measured by KCCQ (difference 2.6 points, -0.7-5.8) or EQ-5D-5L (difference 0.2; -0.02-0.06). Analysis also showed no differences for the individual secondary endpoints of all-cause mortality (HR 0.90; 0.75-1.26), HF-related hospitalization (HR 0.97; 0.66-1.43) and acute MI (10.7% vs. 10.8%; HR 1.01; 0.64-1.60). “PCI did not reduce the composite incidence of all-cause death or HF-hospitalization at a median of 3.4 years, incrementally improve LVEF, or provide a sustained difference in QoL for this high-risk population where approximately one-third of patients died or were hospitalized during follow-up,” Perera said. “Our findings were consistent across all subgroups and for all prespecified outcome measures [but] it is important to note that REVIVED-BCIS2 excluded patients with limiting angina or recent acute coronary syndromes (ACS) and PCI remains an option in these contexts,” he added. “Key messages from the definitive results are that guidelines should be strengthened and clinical practice rationalized.” Guidelines ‘unlikely to be altered’ until more randomized PCI trials Commenting on study findings at ESC Congress, Eric J. Velazquez, MD (Yale New Haven Health, Connecticut, USA) – cardiac surgeon and HF expert who led the pertinent STICH (Surgical Treatment for Ischemic Heart Failure) trial – said: “PCI and CABG are different technically and fundamentally and may lead to distinctly different results. Observational comparisons on the two strategies are also limited, with conflicting results.” “From REVIVED findings, we’ve learned that medical therapy works – and it’s getting better. However, ischemic cardiomyopathy patients still have an unacceptably high mortality rate with an observed 3-year mortality rate of around 20% and 35% at 5-years. European or American guidelines are unlikely to be altered, and more randomized studies of PCI are urgently needed. Velazquez, MD “PCI did not lead to reductions in MI or HF rates, raising questions on the impact of complete and incomplete revascularization in contradistinction to CABG versus OMT. PCI in ischemic cardiomyopathy appears to have no adverse safety signal, and modest short-lived improvements in quality of life, which encourages longer-term follow-up. “This leads to a possible rethinking of patient selection; namely, whether viability is still relevant or a blind alley. [In the meantime,] current guidelines from the ESC and European Association for Cardio-Thoracic Surgery (ESC/EACTS) or American College of Cardiology and American Heart Association (ACC/AHA) are unlikely to be altered. Further randomized studies of PCI are urgently needed.” The joint ESC/EACTS guidelines previously recommended CABG as the first revascularization strategy in patients with multivessel disease and acceptable surgical risk (Class I; level of evidence B) based largely on positive findings from STICH. For PCI, European guidance gave weaker Class IIa recommendations (level of evidence C) for patients with 1-vessel or 2-vessel disease when complete revascularization is possible or in patients with triple-vessel disease based on a Heart Team evaluation. The ACC/AHA guidelines recommended CABG for select patients with LVEF ≤35% without significant left mainstem CAD (LMCAD) (Class IIb; B), but offered no guidance on PCI due to “insufficient” data. Modern evidence stacked against coronary revascularization in severe CAD Although contemporary evidence is showing coronary revascularization is no better than GDMT in patients with extensive CAD, experts noted that follow-up data from REVIVED-BCIS2 are needed to enact any significant guideline changes. In an accompanying editorial, Ajay J. Kirtane, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, USA) also pulled support from coronary revascularization while backing OMT for ischemic cardiomyopathy, but critiqued that REVIVED-BCIS was missing “important” details. “REVIVED is one of the few contemporary randomized trials on revascularization for LV dysfunction. More than anything, this trial supports GDMT to manage LV dysfunction, irrespective of whether revascularization is considered,” Kirtane wrote. “On the heels of the STICH trial, which was twice as large, [operators from REVIVED] were able to perform PCI safety with minimal use of adjunctive hemodynamic support, and unlike STICH, [found] no excess of deaths in the periprocedural period,” Kirtane said. “However, there were no signs of improved outcomes with PCI over a median follow-up of 3.4 years – a finding that differed from what was observed with surgical revascularization in STICH and later confirmed in its extended trial. “As done for STICH, it is imperative for REVIVED investigators to collect longer-term follow-up data to determine whether the [observed] between-group differences will translate to a future decrease in cardiovascular-related death after PCI,” he added. “Until we have these data, we cannot extrapolate outcomes of surgical revascularization with those of PCI plus OMT [since] many questions remain.” As done for STICH, REVIVED investigators must collect longer-term follow-up data to determine whether the between-group differences translate to decreases in CV-deaths after PCI. Kirtane, MD To strengthen the evidence, Kirtane called for more detailed data on anatomical location and extent of CAD in patients along with their correlation with both physiology and ischemic testing. “While [awaiting] results of requisite additional analyses and follow-up data from the REVIVED trial, the prevailing dictum should be to diagnose the joint conditions of congestive heart failure and CAD and provide therapies that are known to be effective for both of these conditions since the therapies that have not yet met that bar are carefully considered against their risks,” he said. STICH vs. REVIVED comparisons ‘apples to oranges’ Perera, also addressing similarities and differences between STICH and REVIVED, said: “STICH had no difference for the 5-year primary outcomes of all-cause mortality because of a 3-fold excess in early mortality within 30 days – and it took 2 years to mitigate the early hit. It was only at the end of the 5-year follow-up period that investigators saw a deviation and favor for CABG, leading to the extended 10-year STICH follow-up where the curves continued to diverge. “Something different happened in our trial; namely, there was no signal of excess mortality with PCI – the curves were superimposed all the way through. Also, a lot of time has passed since STICH, which started recruitment in the early 2000s, and STICH only enrolled optimal surgical candidates (median age: 59) whereas REVIVED enrolled a more real population (median age: 70). We can conclude that PCI should not be offered to stable patients with ischemic LV dysfunction if the sole aim is to provide prognostic benefit. Perera, MD “Evolution in medical therapy during that time has also been phenomenal. All these factors combined have an impact on the different results, meaning the trials are different in many ways – so it’s apples to oranges.” Regarding Kirtane’s critique of REVIVED patients having a “relatively modest degree of CAD,” Perera said: “There was an implication that most patients had modest CAD (most with 2-vessel disease and few with triple-vessel disease), but this was the very reason we, as investigators, believed the 2- and 3-vessel disease classification was suboptimal. The median BCIS-Jeopardy score was 10, which is high. We also included LMCAD, which was never done before in an RCT. This was a severe disease population. “There were also comments about needing more detail on the types of revascularizations performed – which sounds about right – and we hope to examine them in follow-up data.”

September 29, 2022 6190
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SummitMD

POST-PCI raises red flags for routine functional testing in high-risk PCI patients

Routine functional testing did not outperform standard care for major outcomes, including survival at 2-years, in high-risk patients undergoing percutaneous coronary intervention (PCI), a randomized study recently showed. The “Pragmatic trial comparing symptom-Oriented versus routine Stress Testing in high-risk patients undergoing Percutaneous Coronary Intervention” (POST-PCI) trial found no significant difference between the two follow-up strategies for the composite primary outcome of all-cause mortality, myocardial infarction (MI) and hospitalization for unstable angina (5.5% vs. 6.0%; HR 0.90, 95% CI, 0.61-1.35; p=0.62). Principal investigator Duk-woo Park, MD, PhD (Asan Medical Center, Seoul, South Korea) presented the results at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, Spain on Aug 28 with results published simultaneously in the New England Journal of Medicine (NEJM). Duk-woo Park, MD, PhD (Asan Medical Center, Seoul, South Korea) presents POST-PCI findings at the ESC Congress 2022 held in Barcelona, Spain on Aug 28. “There were no significant between-group differences for the primary composite of death, MI or hospitalization for unstable angina at 2-years between PCI and standard care,” Park said at the late-breaking science session. “The incidence of events was lower than expected in the two investigational groups, possibly due to improved techniques for complex PCI along with general improvements in cardiovascular care over the years.” “Nevertheless, routine stress testing was associated with more invasive coronary angiography and repeat revascularization after 1-year without a significant reduction in major cardiovascular events or mortality,” he said. “Our trial does not support active surveillance with routine functional testing as a follow-up strategy in high-risk patients undergoing PCI.” POST-PCI The multicenter, pragmatic, randomized superiority trial included high-risk patients undergoing PCI at 11 centers in South Korea to evaluate whether routine stress testing would significantly reduce ischemic cardiovascular events or mortality over standard care. Our trial does not support active surveillance with routine functional testing as a follow-up strategy in high-risk patients who undergo PCI. Duk-woo Park, MD, PhD Also examined was whether routine functional testing changed post-PCI management practice or other preventive strategies, including preemptive angiography, revascularization and more aggressive medical therapies. Investigators enrolled 1,700 patients (mean age: 65 years; 80% male) and randomized them by trial center or diabetes status to post-PCI management with routine stress testing at 1-year after PCI (n=850) or standard care (n=850). Patients’ high-risk anatomical characteristics included left main (LM) disease (21.0%), bifurcation lesions (43.5%), multivessel disease (69.8%) and diffuse long lesions (70.1%). High-risk clinical characteristics included medically-treated diabetes (38.7%) and prior treatment with DES (96.4%). Other high-risk factors included restenosis, bypass graft disease, chronic renal failure and enzyme-positive acute coronary syndrome (ACS). All patients underwent successful PCI with contemporary drug-eluting stents, bioresorbable scaffolds or drug-coated balloons. Cardiac stress testing included exercise echocardiography (ECG), nuclear stress imaging or stress ECG. The composite primary endpoint was defined as death, MI or hospitalization for unstable angina 2-years after randomization. Secondary endpoints included individual components of the primary composite outcome, composite of death or MI, all-cause hospitalization, invasive coronary angiography and repeat revascularization procedures. Results showed that routine functional testing had a statistically non-significant trend for the primary outcomes compared to standard care (5.5% vs. 6.0%; HR 0.90, 95% CI, 0.61-1.35; p=0.62). We must refrain from prescribing surveil¬lance stress testing after PCI in the absence of other clinical signs or symptoms suggestive of stent failure. Jacqueline E. Tamis‑Holland, MD For secondary outcomes, there were no significant differences for the individual components of all-cause mortality (routine testing 2.8% vs. standard care 3.3%; HR 0.82, 0.48-1.43), MI (0.5% vs. 1.2%; HR 0.40, 0.13-1.28) and hospitalization for unstable angina (2.3% vs. 1.7%; HR 1.36, 0.68-2.72). Outcomes for invasive cardiac catheterization (11.9% vs. 9.0%; log-rank P=0.07) and repeat revascularization (7.8% vs. 5.6%; log-rank P=0.09) also showed no significant improvements with functional stress testing. Furthermore, landmark analysis performed at 1-year and 2-years after PCI showed functional testing was associated with a 2-fold higher incidence of invasive coronary angiography that did not lead to meaningful reductions in all-cause mortality or MI rates. On study limitations, Park cited the possibility of ascertainment bias due to unmasked follow-up strategies (from patients and investigators); varying diagnostic accuracy of the stress tests; cases of nonadherence to stress testing; and no analysis of quality of life, cost-effectiveness or radiation exposure. ‘Compelling’ evidence nudges ‘post’-surveillance testing era, guideline changes? The new evidence could spark changes in coronary artery guidelines, an expert commented, shifting the existing weak recommendations on surveillance testing to a Class III recommendation for high-risk patients, indicating contraindication. “The POST-PCI trial provides compelling new evidence for a future class III recommendation for routine surveillance testing after PCI,” wrote Jacqueline E. Tamis‑Holland, MD (Mount Sinai Morningside Hospital, New York, USA) in a NEJM editorial published Aug 28. “Until then, we must refrain from prescribing surveil¬lance stress testing to our patients after PCI, in the absence of other clinical signs or symptoms suggestive of stent failure.” Currently, the 2021 American College of Cardiology, American Heart Association and Society of Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) guidelines have no recommendations on routine stress testing after revascularization, citing limited RCT data on the subject. The 2018 European Society of Cardiology and European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines gave a weak Class IIb recommendation (level of evidence C) for surveillance with non-invasive imaging-based stress testing in high-risk patients 6-months after revascularization. European guidelines also gave the Class IIb recommendation (level of evidence C) for late surveillance angiography (3-12 months after PCI) in high-risk patients (i.e., unprotected LM stenosis) and routine non-invasive imaging-based stress testing 1 year after PCI or 5 years after coronary artery bypass graft (CABG). POST-PCI provides compelling new evidence for a future class III recommendation for routine surveillance testing after PCI. Tamis‑Holland, MD Despite weak guideline recommendations on surveillance testing, real-world observational studies have reported their widespread use in patients after CABG and PCI, with more than half of patients reported to have undergone functional testing within 2 years of coronary revascularization. “Studies have demonstrated a substantially high rate of repeat revascularization in hospitals that had the highest frequency of stress testing after PCI, and this did not translate to lower risk of MI or death during long-term follow-up,” Tamis-Holland wrote. Tamis-Holland noted that POST-PCI results also back findings from ISCHEMIA - the landmark, randomized trial on high-risk, moderate-to-severe ischemic patients on stress testing that reported no substantial difference between an initial invasive strategy and conservative treatment. In ISCHEMIA, around 20% had previously undergone PCI and roughly one-third had symptoms of angina 4 weeks before randomization. “Despite the inclusion of only high-risk patients [in ISCHEMIA], there was no substantial difference between the two strategies in the primary clinical endpoint at 5 years of follow-up,” she observed. “The extent of ischemia on stress testing did not identify a subgroup of patients that derived a benefit from an invasive strategy.” “Collectively, the trials highlight the lack of benefit with rou¬tine stress testing in asymptomatic patients, underscoring the importance of proper procedural techniques and aggressive secondary prevention to improve outcomes after PCI.”

September 23, 2022 13569
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AP VALVES & SH 2022

SAVR always better for younger AS? 'Durability data up to 10-years greenlights TAVR for patients bet...

"Meaningful" long-term data on valve durability are lacking, an expert said, but existing ones can aid decision-making between transcatheter aortic valve replacement (TAVR) and surgery in younger patients with aortic stenosis (AS) at lower operative risk. "Long-term valve durability has surfaced as the most important issue for decision-making between TAVR and surgical aortic valve replacement (SAVR), especially in younger patients with longer life expectancy and few comorbidities," said Duk-woo Park, MD, PhD (Asan Medical Center, Korea) at the Grand Walkerhill Seoul in South Korea during the AP VALVES & STRUCTURAL HEART 2022 conference on Aug 11. "What matters is durability beyond 10 years because more TAVR candidates are younger with fewer comorbidities," Park said. "But meaningful long-term durability data on TAVR valves are expected no sooner than 2025." "Current evidence says TAVR can be considered for younger patients between 65 and 70, provided that coronary tomography angiography (CTA) shows anatomy suitable for TAVR with no other co-existing aortopathy, valve or coronary issues, and when patients are strongly opposed to surgery," he said. "Considering the increasing importance of lifetime management of AS, the ‘TAVR first' approach should ensure future coronary access, future TAVR-in-TAVR and future SAVR after TAVR." Duk-woo Park, MD, PhD (Asan Medical Center, Seoul, South Korea) presents optimal decision-making for TAVR and SAVR on Aug 11 at the 11th AP VALVES & STRUCTURAL HEART 2022 at the Grand Walkerhill Seoul in South Korea. Age becomes crucial for optimal decision-making between TAVR, SAVR An optimal AVR strategy for younger patients (

September 20, 2022 3355
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AP VALVES & SH 2022

Data on TAVR-related stroke 'not enough, hard to justify routine EPD use except in BAV, ViVs,'

The benefit of using cerebral embolic protection devices (EPDs) to prevent stroke related to transcatheter aortic valve replacement (TAVR) remains uncertain, an expert said, but patient subgroups nevertheless stand to benefit from routine use. "Although EPD usage is increasing in the United States, it's difficult to justify - at the present moment - their selective use except for cases of bicuspid aortic stenosis (AS) or valve-in-valve (ViV) procedures," said David Joel Cohen, MD (Cardiovascular Research Foundation; St. Francis Hospital, New York, USA) on Aug 11 at AP VALVES & STRUCTURAL HEART 2022 held at the Grand Walkerhill Seoul in South Korea. David J. Cohen, MD asks panelists on routine EPD use for preventing TAVR-related stroke during an AP VALVES & SH 2022 session held at the Grand Walkerhill Seoul in South Korea on Aug 11. EPDs are mesh filters that clear out debris during a TAVR procedure, which are thought to prevent cerebrovascular events like major or minor stroke, transient ischemic attacks (TIA), neurocognitive decline and "silent" cerebral infarcts, which are significant but unpredictable complications of TAVR. However, lacking concrete data on the clinical efficacy of EPDs for preventing or protecting against TAVR-related stroke and other related complications has confounded attempts to use them routinely in the clinical setting. EPDs have been proven to capture TAVR procedure-related debris and likely reduce the volume of new brain lesions but we're just not that good at predicting stroke, David Joel Cohen, MD Cohen - who specializes in researching the cost-effectiveness of novel devices and procedures in interventional cardiology - noted that the problem poses a significant challenge from both clinical and economic standpoints. Analysis on 129,000 TAVR cases from Medicare Claims in the United States from 2012 to 2017 showed that TAVR-related in-hospital stroke (4.3%) was associated with an increased risk of mortality up to 5 years and a $9,000 annual increase per patient, he said. Several EPDs - including Sentinel (Claret Medical; Boston Scientific, Minnesota), TriGuard3 (Keystone Heart, Florida), ProtEmbo (Protembis, Germany), Emblok (Innovative Cardiovascular Solutions, US), Emboliner (Emboline, CA, USA) and Point-guard (Transverse Medical Inc, Colorado, USA) - were developed as potential solutions. Sentinel is the only device to have gained American and European approval based on the SENTINEL IDE trial1, but approval came through for its ability to clear out debris - not for preventing stroke. Routine use of EPDs is also contested due to major analyses, like that of the observational TVT Registry, that showed EPD’s efficacy to be "more modest than originally thought." The study2 led by Cohen and colleagues on embolic protection for TAVR examined the rate of in-hospital death or stroke in 132,248 TAVR patients treated with EPDs (n=12,409) or without (n=110,777) and employed both instrumental variable (IV) and propensity-weighted analysis. Results of IV analysis showed a statistically non-significant trend for EPDs to reduce TAVR-related stroke (EPD 2.4% vs. no EPD 2.6%; RR 0.93, 95% CI, 0.76-1.11, p=0.47). Conversely, the propensity-weighted analysis found a small, but statistically significant stroke reduction with EPDs (1.30% vs. 1.58%; RR 0.82, 95% CI, 0.69-0.97). Investigators concluded that embolic protection devices were "generally safe" and did not increase rates of vascular complications, major bleeding or device failure. On the discrepancy between the two analytical approaches, Cohen explained that side-by-side comparisons showed no significant difference between them, except for a wider variance with the IV analysis. Investigators also observed a strong trend between EPDs and stroke reduction in two subgroups:, bicuspid aortic valves (BAVs) and ViV procedures, These findings signaled the need for larger randomized controlled trials, Cohen said. The two right answers on who needs EPDs in 2022 is everybody or nobody, Cohen "Aside from the substantial stroke reductions for patients with bicuspid anatomy and ViVs, patient selection for stroke remains fairly challenging," he said. "Although we created the TVT Stroke Model3 to identify risk factors for stroke, it had a poor c-statistic of 0.62 - and considering a value of 0.5 would essentially be a coin flip - we concluded that the model is good for calibration but not for discrimination. "So far, we haven’t been able to see a decline in neurocognitive function in trials, but to be fair, the trials so far have been small," he added. "We need more research on the long-term neurocognitive effects of non-disabling and clinically-silent strokes since evidence has shown emboli and asymptomatic cerebral emboli are associated with neurocognitive decline and because those would ultimately be the major targets for these devices." The ongoing PROTECTED-TAVR (n=3,000) and BHF-PROTECT TAVI (n=7,730) studies - two large-scale randomized controlled trials (RCTs) rolled out in the US and UK, respectively - are expected to shed long-awaited answers on the efficacy of the Sentinel device and stroke prevention. Perspectives on current, future routine EPD usage in field When asked about routine use of EPDs in clinical practice based on existing data, Cohen quipped: "The two right answers on who needs EPDs in 2022 is everybody or nobody. There isn’t much case selection because we just cannot detect strokes that well." "EPDs have been proven to capture TAVR procedure-related debris - and likely reduce the volume of new brain lesions. And we’re just not that good at predicting stroke," he said. "In Kansas City, I used them only for bicuspid and ViV procedures because of financial barriers but in New York - where I am now - we use them 100% except for cases of unfavorable anatomy or position. "When the evidence is not that strong, that’s the right thing to do." When the question was turned to session panelists, a show of hands showed only 3 out of 8 clinicians used EPDs routinely in clinical practice. We need more research on the long-term neurocognitive effects of non-disabling and clinically-silent strokes because those would ultimately be the major targets for embolic protection devices. If future studies were to demonstrate high prevention rates ("70-80%") for large strokes, Cohen hypothesized, then the recommendation for using EPDs would be upped to 100%, although concerns of trials like PROTECTED-TAVR being underpowered are limitations. "Results from PROTECTED-TAVR are coming up in 5 weeks at TCT 2022 and - even though I don’t know the results yet- it’s hard to imagine a 50% reduction with these observational data - it just doesn’t seem to be there," he said. "Even if Sentinel doesn’t reduce all strokes, a good signal seems to be emerging for large strokes, despite the problem of the studies being underpowered," he added. "If EPDs do reduces large strokes, we should be using them for everyone, because that’s compelling evidence. Regardless, I’m just glad we’re getting the evidence needed to move forward - it’s been frustrating not to have it."

September 20, 2022 4646
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AP VALVES & SH 2022

Not just alternative to SAVR: 'TAVR has become standard of treatment for severe, symptomatic AS'

Transcatheter aortic valve replacement (TAVR) is expanding rapidly to younger and lower-risk aortic stenosis (AS) patients, becoming the therapy of choice in select subgroups and trumping even surgical aortic valve replacement (SAVR), an expert said. "At Asan Medical Center (AMC), the rule is that TAVR is the standard treatment when tissue valves are needed for symptomatic severe AS patients over 65 years of age," said Seung-jung Park, MD, PhD (AMC, Seoul, South Korea) at AP VALVES & STRUCTURAL HEART 2022 on Aug 11, which ran for two days at the Grand Walkerhill Seoul in South Korea. As chairman of AMC's Heart Institute, Park highlighted TAVR advances worldwide and at the medical institution over the past decade. Seung-jung Park, MD, PhD presents on improvements of TAVR worldwide and at Asan Medical Center at the AP VALVES & SH 2022 at the Grand Walkerhill Seoul in South Korea on Aug 11. Major randomized controlled trials (RCTs) on TAVR and transcatheter heart valves (THVs) - including the CoreValve, Evolut and Sapien valves - laid the groundwork for device approval in both Europe and the US, ushering in the "era of TAVR" for patients who had no alternative to surgery. TAVR has become comparable with surgery 5 to 8 years since its introduction and SAVR has become the alternative Seung-jung Park, MD, PhD The landmark PARTNER 31 and the Evolut Low Risk2 trials, published simultaneously in the New England Journal of Medicine (NEJM) in May 2019, backed the case for TAVR in lower operative risk groups after results favored TAVR over SAVR for the 30-day and 1-day endpoints of death, disabling stroke or rehospitalization. Meta-analysis3 of the NOTION, SURTAVI, PARTNER 3 and Evolut Low Risk trials, published in the Journal of the American College of Cardiology (JACC) in Sep 2019, also showed 1-year outcomes favoring TAVR over SAVR for all-cause mortality (2.1% vs. 3.5%, RR 0.61; 95% CI, 0.39-0.96, I2=0%) and cardiovascular death (1.6% vs. 2.9%, RR 0.55, 0.33-0.90, p=0.02, I2=0%). TAVR also had lower rates of disabling stroke (0.5 vs 1.7%), atrial fibrillation, life-threatening or disabling bleeding and acute kidney injury but higher rates of permanent pacemaker implantation and moderate or severe paravalvular leak (PVL). On the heels of the major trials, the US Food and Drug Administration (FDA) greenlighted expanded indications for TAVR, for patients at low surgical risk in Aug 20194, causing seismic shifts in both American and European guidelines and boosting the once experimental procedure to a standard of care. The 2020 American College of Cardiology and American Heart Association (ACC/AHA) guidelines gave a Class I recommendation for TAVR for patients over 65 years and the 2021 European Society of Congress and European Association of Cardio-Thoracic Surgeons (ESC/EACTS) guidelines greenlighted TAVR with a Class I indication for patients over 75 years5. "More research is needed for TAVR in bicuspid aortic valve (BAV) disease, aortic and mitral bioprosthetic valve failure, low-flow, low-gradient AS, high-risk aortic regurgitation (AR) and routine use of cerebral protection devices, among others," he said. "Nevertheless, TAVR has become comparable with surgery 5 to 8 years since its introduction, and SAVR has become the alternative." AMC Celebrates 97% Procedural Success Rate During 22 Years of TAVR Following the first operation at AMC in 2010, - undertaken with TAVR pioneer Alain G. Cribier, MD(University of Rouen's Charles Nicolle Hospital, Paris, France),6 - TAVR operations at the South Korean hospital skyrocketed to over 250 cases per year. Last June, AMC's Heart Institute announced becoming the first in Asia to complete 1,000 TAVR cases7 and reported tallying 1,300 cumulative cases this year. Analysis found AMC's Heart Team achieved a procedural success rate of 96.8% (1,101/1,137 patients) with low rates of new permanent pacemakers (6.9%) and moderate or severe paravalvular leaks (4.3%) despite operating on an elderly, high-risk and severe-disease population. The rule at AMC, for tissue valves, is that TAVR has become the standard of treatment in patients with symptomatic severe AS patients over 65 Park Baseline characteristics showed the average patient was 80 years old, 47% were male and the mean Society of Thoracic Surgeons (STS) risk score was 4. Major comorbidities included hypertension (79.1%), diabetes (34.9%), chronic obstructive pulmonary disease (22%), atrial fibrillation (12.4%), stroke (11.7%) and peripheral vascular disease (5.1%). Comparing 30-day and 1-year outcomes between cases from 2021 and all cumulative cases at AMC showed improvements in the endpoints of all-cause mortality (All cases 1.7% vs. 2021 cases 1.9%), and major, disabling strokes (1.0% vs. 0.3%). TAVR also recorded improvements for the 30-day and 1-year endpoints of major vascular complications (5.3% vs. 0.0%), new permanent pacemaker implementation (6.9% vs. 3.0%) and moderate or severe PVR (4.3% vs. 1.1%) - which were aided by implementing a unique "minimalist approach." "Since the first case in 2010, AMC developed a minimalist approach coined the 'MAC' that helps simplify the TAVR procedure," Park said. "Along with impeccable heart team collaboration, we also developed a meticulous pre-TAVR CT measurement algorithm that aids device selection. The MAC approach implies no general anesthesia, no transesophageal echocardiography (TEE), 30-minute procedures, 1-day stays in the CCU, discharge within 3 days and a cardiac rehabilitation program, Park said. Outcomes between balloon-expandable and self-expandable valves were also comparable, although self-expandable valves had a significantly higher rate of new permanent pacemakers (5.3% vs. 15.4%). At AMC, the Edwards Lifesciences’ Sapien 3 valve (73%) accounted for most implants, followed by Sapien XT (Edwards Lifesciences; 10%), Evolut R & PRO (Medtronic; 8%), and CoreValve (Medtronic; 8%). "Although valve durability remains a major issue and more research is needed on patient subgroups, outcomes at AMC have improved over time, thanks to MAC," Park said. "And the rule here, for tissue valves, is that TAVR has become the standard of treatment in patients with symptomatic severe AS patients over 65."

September 16, 2022 6625
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