No ICD Benefit for Older HF Patients

A new study published in British Medical Journal has found that patients over the age of 65 who received implantable cardioverter defibrillators (ICDs) during hospitalization for heart failure (HF) or other acute comorbidities did not benefit from the device.

In this retrospective cohort study, researchers used the ICD registry of the Centers for Medicare and Medicaid Services (CMS) (2005-08); the ICD registry of the ACC’s National Cardiovascular Data Registry (NCDR) (2005-08); a nationwide heart failure registry aggregated from several quality improvement and accreditation programs, including the American Heart Association’s Get With the Guidelines program (2005-08); and Medicare institutional and non-institutional claims (2004-09). Data from the registries were linked to Medicare claims data using date of birth, sex, admission date for implantation, and provider identifiers.

The study population included 23,111 patients aged 66 and over with heart failure, 5,258 with ICDs, and 17,853 patients without ICDs who had acute admissions for heart failure or any comorbidities and who were eligible for ICD therapy in primary prevention. Patients with ICDs were younger and more likely to be men, had lower ejection fraction, more physician visits, their heart failure was more likely to have an ischemic cause and they had a higher prevalence of noncardiac admissions. The primary outcome was all-cause mortality and the secondary outcome was sudden cardiac death.

The average follow-up time was 2.8 years, in which 12,293 (53%) patients died. Mortality curves for the patients with and without ICDs began to diverge immediately after implantation (2.4% [2.0% to 2.8%] vs 12.7% [12% to 13%] at 30 days). Crude mortality at one year was lower for ICD recipients than for eligible patients without an ICD (18% [17% to 19%] vs 39% [38% to 40%] at one year and 40% [38% to 41%] vs 60% [60% to 61%] at 3 years). However, the crude mortality in these hospitalized Medicare patients with an ICD at 1 year was similar to the mortality seen at 3 years in trials of ICDs in ambulatory recipients. Patients who received an ICD did not have a substantially different risk of mortality or sudden cardiac death than those who did not have an ICD. The researchers found no significant differences in ICD effectiveness among most demographic subgroups, except in the small group of patients aged over 81. In this group, ICD use was associated with a lower mortality risk but not with a significant reduction in risk of sudden cardiac death. There was a trend towards benefit of ICDs implanted during acute admissions to hospital in reducing mortality or sudden cardiac death in patients who had a myocardial infarction more than 40 days before implantation, left bundle branch block, or lower serum B type natriuretic peptide, although these also did not reach significance.

The authors explain that patients in this study may not have seen the same benefits from ICDs as patients in past studies examining healthier ambulatory patients. They believe these differences are likely explained by differences in the patient population—the subjects in this study were older and had a higher burden of heart failure and other comorbidities at baseline, all of which increase the likelihood of mortality that will not be prevented with an ICD.

“Our results extend the understanding of the clinical effectiveness of ICDs in elderly patients admitted to the hospital, who are not typical of patients in trials,” write the authors, led by Chih-Ying Chen, PhD, of the division of pharmacoepidemiology and pharmacoeconomics at the department of medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, MA. “Patients admitted for acute exacerbation of heart failure or other co-morbidities might be at greater risk both during ICD implantation and for non-arrhythmic events after discharge.” They add that, in these patients, “it might be appropriate to delay the decision to implant a primary ICD until they have been discharged and can be re-evaluated in the outpatient setting.” These findings give no reason to restrict ICDs for older patients with heart failure who otherwise are similar to patients in pivotal ICD trials. Futures research is needed to identify other groups of older patients who may or may not benefit from ICDs.

“Shared decision-making regarding primary prevention ICD has been recommended to involve explicit consideration of patient preferences and the likelihood of competing risks for mortality in all patients,” the authors conclude. “These decisions require particular scrutiny for patients admitted to hospital for exacerbation of heart failure or other acute causes.”

Chen C, Stevenson LW, Stewart GC, et al. BMJ. 2015;351:h3529.

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Interventional Field Lacks Female Cardiologists

A recent study from the National Cardiovascular Data Registry (NCDR) CathPCI Registry has found that female interventional cardiologists are uncommon and they often perform only a small number of percutaneous coronary intervention (PCI) procedures.

In the study, published in Catheterization and Cardiovascular Interventions, researchers examined 2,465,685 PCI procedures performed at 1,431 U.S. hospitals between July 1, 2009, and June 30, 2013. Female operators accounted for only 412 (4.5%) of 9,179 interventionalists who performed PCI procedures during this time period. Only 511 (36%) of the hospitals had at least one female operator. The researchers found a greater proportion of female operators in the Northeastern and Midwestern parts of the country. Female interventionalists were more likely to practice in academic than non-academic institutions and 62% of these academic institutions were in urban areas. Additionally, 41% of female interventionalists were the only female interventional cardiologist at their institution.

Of the PCI procedures included in the study, only 3% were performed by female operators. Although the number of PCI procedures performed by female operators has increased annually, the majority are still low-volume operators. While male operators performed a median number of 69 PCI procedures per year, female operators performed a median of 48 procedures per year. This number is below the 50 procedures recommended in the 2013 American College of Cardiology/American Heart Association guideline. Compared to male operators, female operators performed a higher proportion of cases among patients with ST-segment elevation myocardial infarction (STEMI) or cardiogenic shock. The rate of in-hospital mortality was very low among patients with PCI performed by female interventionalists, and there was no significant difference in mortality between female operators who performed more than 50 PCI procedures per year and those who performed less than 50 procedures per year.

This is the first national report of practice patterns and outcomes of PCI procedures performed by female interventionalists. The authors, led by Tracy Y. Wang, MD, MHS, MSC, FACC, explain that existing barriers contribute to the low number of female interventionalists. “Women operate in relative isolation with few opportunities for networking and mentorship with other female interventionalists within the same practice,” they write. “Acknowledging that the demand for interventionalists will continue to be stimulated by procedural innovations and trial results, efforts are needed to broaden the appeal of this specialty to female candidates.”

Wang TY, Grimes C, Ortega R, et al. Cathet Cardiovasc. Intervent. 2015; doi:10.1002/ccd.26118. [Epub ahead of print]

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Does OCT Influence PCI Decision-Making?

Optical coherence tomography (OCT) findings influence physician decision-making and procedural strategy in pre-percutaneous coronary intervention (PCI) and post-PCI in most patients, according to the results of the ILUMIEN I study published in European Heart Journal.

In this prospective, non-randomized observation study, patients presented with stable angina, unstable angina, or non-St segment myocardial infarction (NSTEMI) and underwent elective or ‘ad hoc’ PCI. A total of 418 patients (467 lesions) were included. Patients had a mean age of 64.6+10.2, and 24.5% were female. Presentation was stable angina (63%), unstable angina (22%), NSTEMI (11%), or silent ischemia (4%). Previous MI was present in 24% and prior PCI in 20%.

Pre-PCI fractional flow reserve (FFR) was obtained in 379 patients (423 lesions), and pre-PCI OCT was obtained in 411 patients (459 lesions). Following pre-PCI OCT, treatment planning was modified in 55% of patients (57% of all stenosis), in 7-80% of cases per site. Post-PCI FFR was documented in 83% of patients (84% of all lesions) and post-PCI OCT in 98% of all patients/stenoses. Post-PCI result was deemed as unsatisfactory by OCT imaging which led to further optimization in 106 patients (25%).

Changes in planned treatment strategy as a result of pre-PCI OCT included changes in selection of stent length (shorter in 25%, longer in 43%, unchanged in 32%). Stent diameter selection decreased in 31%, increased in 8% and was unchanged in 87%. The number of implanted stents per patients did not change. Post-PCI OCT findings prompting further procedural optimization were malapposition, under-expansion and edge dissection, which lead to additional in-stent post-dilation (81%), new stent placement (13%) or both (3%). The number of stents per patient was significantly higher after optimization based of post-PCI OCT. OCT findings also led to increased fluoroscopy time and procedure duration.

The authors, led by William Wijns, MD, PhD, write that “in-hospital findings of ILUMIEN I do raise the intriguing hypothesis that safety of PCI could be further improved by reducing the rates of perioprocedural MI.” In over half of the cases in the trial, the planned strategy was modified after OCT. They add that the “[a]nalysis of 1-year outcomes of ILUMIEN I, including additional events, will likely contribute to further defining which OCT parameters and degree of abnormality require optimization, along with other studies.”

Wijns W., Shite J., Jones MR, et al. Eur Heart J. 2015;Aug 4. [Epub ahead of print]

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NCDR Data Finds a Shift in the Use of Mechanical Circulatory Support in PCI

Between 2009 and 2013, the use of intra-aortic balloon pump (IABP) has decreased concurrently while the use of other mechanical circulatory support (MCS) devices has increased, according to a recent study in Circulation. The study also found that the use of IABP and other MCS varied across hospitals.

For this study, the Amneet Sandhu, MD, and colleagues examined data from the ACC’s National Cardiovascular Data Registry (NCDR) CathCPI Registry. The study population consisted of 76,474 patients undergoing PCI in the setting of cardiogenic shock at 1,429 hospitals participating the in NCDR CathPCI registry from July 1, 2009, to September 30, 2013.

The researchers found that 41,286 (54%) received no MCS, 29,730 (39%) received IABP only, 2,711 (3.5%) received other MCS only and 2,747 (3.6%) received IABP in addition to another MCS device. In comparison to patients who did not received MCS, patients who did were more likely to have heart failure within the prior 2 weeks, left ventricular systolic dysfunction, or cardiac arrest within 24 hours. Patients receiving MCS were also more likely to be in cardiogenic shock at the start of PCI in comparison to those who received no MCS.

At the beginning of the study period, 45% of patients undergoing PCI for cardiogenic shock received IABP and 6.7% received another MCS. There was a 0.25% decline in patients receiving IABP per quarter until Quarter 4 of 2012. After the publication of the IABP-SHOCK II trial, which found no benefit of routine IABP use in patient with acute myocardial infarction, the percentage of patient receiving IABP fell by 1% compared to the pre-publication period. The quarterly rate of decline was not significantly different to the rate prior to publication. The proportion of patients receiving other MCS increased an average of 0.02% per quarter until Quarter 4 of 2012 and no change was seen after the publication of IABP-SHOCK II. “Despite [the] emerging data on newer MCS therapies, we found no significant increase in the use of [other MCS] technologies to offset the observed decline in IABP use,” the authors write.

The researchers also found a hospital-level and geographic variation in the use of IABP and other MCS. The probability of no MCS use at the median hospital was 55%, while the probability of IABP use at the median hospital was 42%. The use of other MCS was clustered at a small number of hospitals and these hospitals were more likely to be teaching hospitals.

In a secondary analysis, the Sandhu and colleagues examined the rate of use of IABP and other MCS for high-risk PCI. They discovered a small temporal decline in IABP use and unchanged use of other MCS in this setting. “Our findings likely reflect continued uncertainty of clinical benefit in the use of IABP and other MCS for high risk PCI,” they write.

Finally, the authors note that the intent of the study was to provide a contemporary description of the use of IABP and other MCS in cardiogenic shock and high-risk PCI. The explain that “as the decisions to use MCS is dependent on complex interactions between patient, provider, and system factors that are not readily ascertained in observation data, combined with the highly clustered use of [other MCS] therapies at a select number of facilities, analyses of patient outcomes based on the type of MCS delivered were not intended and cannot reasonably be made[…] Large scale randomized clinical trials remain necessary to guide our understanding of the impact of newer MCS therapies on patient outcomes.”

Sandhu A, McCoy LA, Negi SI, et al. Circulation. 2015; doi:10.1016/S0735-1097(15)60168-1.

Keywords: CardioSource WorldNews Interventions, Catheterization, Comorbidity, Defibrillators, Implantable, Fluoroscopy, Heart Failure, Hospitalization, Stents

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