Even With More Experience, Transapical TAVR Offers No Better QoL Than Surgery
While experience with transapical TAVR has grown in recent years, the lessons learned have failed to translate into improved quality of life (QoL) at 12 months compared with what was seen in the PARTNER randomized trial for the percutaneous approach or for surgical replacement. The findings were published online June 9, 2015, ahead of print in Circulation: Cardiovascular Quality and Outcomes.
David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), and colleagues compared health-related QoL among 3 groups:
- 875 patients who underwent transapical TAVR in the nonrandomized PARTNER continued access registry, which began enrollment in late 2009 subsequent to the RCT
- 99 patients in PARTNER Cohort A who, after being deemed ineligible for transfemoral TAVR, were randomized to transapical TAVR
- 80 patients in PARTNER Cohort A who, also deemed ineligible for transfemoral TAVR, were randomized to surgical aortic valve replacement (SAVR)
QoL was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12 (SF-12), and the EuroQoL-5D (EQ-5D) at baseline and at 1, 6, and 12 months after intervention.
Early Advantage of Registry Patients Abates
Registry patients tended to be older than either of the randomized cohorts and to have previously undergone balloon aortic valvuloplasty. Compared with patients randomized to transapical TAVR, the registry patients were more likely to have prior PCI and less likely to have comorbid cerebrovascular disease. Compared with those randomized to surgery, they were less likely to have diabetes.
At baseline, mean KCCQ summary score (primary endpoint) was similar among the 3 groups: 44.2 for registry patients, 40.6 for those randomized to transapical TAVR, and 45.4 for those randomized to SAVR.
Each of the treatments improved QoL compared with baseline at 1, 6, and 12 months in terms of mean change in KCCQ summary score. Although SAVR patients did not show improvements at 1 month in scores for KCCQ physical or social limitation or in those for the SF-12 physical or mental components, by 6 and 12 months all groups had gains over baseline.
However, in longitudinal mixed effects models, at none of the follow-up points did the registry patients have better mean KCCQ summary scores than those randomized to transapical TAVR or surgery in PARTNER (table 1).
The nonrandomized cohort did show some early advantages for the individual KQQC measures of total symptoms and social limitation as well as for SF-12 mental and EQ-5D utilities, but these disappeared by 6 or 12 months.
“Although we did find some evidence that early [health-related] QoL outcomes have improved with greater experience, these differences were modest at best, and there remained no evidence of [such improvements] compared with SAVR in either the short or the long term,” the researchers say.
In an email interview, Dr. Cohen noted that an additional message “is that just because a procedure is ‘less invasive,’ it doesn’t mean that it’s necessarily less painful.” Transapical does not meaningfully reduce post-operative pain compared with SAVR, he said, though it could “still offer other advantages.”
An Evolving Landscape
Peter C. Block, MD, of Emory University (Atlanta, GA), pointed out to TCTMD in an email that not only transapical TAVR has evolved. “Remember that cardiac surgical techniques and experience have not ‘stood still’ during the post-TAVR years,” he said. With transapical, ”[v]entriculotomy techniques have improved, possibly resulting in less left ventricular dysfunction [postprocedure], and techniques to minimize post-op discomfort have evolved as well. Both might impact QoL.”
Today, he said, practice “has shifted further toward a [transfemoral] approach because of smaller delivery catheter sizes making many more patients with moderate atherosclerotic cardiovascular disease in their iliofemoral vessels candidates for [that route].”
The current study only what was happening during “an ‘early’ time in TAVR evolution,” Dr. Block emphasized. “Times have changed.” Given the expanding possibilities—including improved device technology, alternative access, and “minimalist” TAVR under conscious sedation, he predicted, “My bet is that [transapical] will be sparingly used as TAVR continues to evolve.”
Indeed, while “most patients who undergo transapical TAVR do so because they do not have acceptable femoral access,” Dr. Cohen told TCTMD, “there are many other alternative access sites available today including direct aortic, subclavian, transcaval, and transcarotid access. In my anecdotal experience, many of these approaches appear to be associated with substantially less postoperative pain than the [transapical] approach.”
Issac George, MD, of Columbia University Medical Center (New York, NY), said that in PARTNER “some patients just posed prohibitive risk from any procedure but were unfortunately stratified to [transapical] TAVR by virtue of their poor vascular access. This strategy was in fact counterproductive (ie, taking the highest risk patient and pairing them with the highest risk procedure).”
When done in lower-risk patients, transapical TAVR has “lower rates of morbidity and mortality, though still not low as [transfemoral],” he reported. The current results, Dr. George added, “must force us to continue to innovate the procedure to reduce incision size, incorporate standardized apical closure, and adopt pain control algorithms that will help get patients out of the hospital faster.”
Transaortic TAVR Could Be Superior
According to Dr. Cohen and colleagues, the transaortic approach may hold potential advantages over transapical including “avoidance of a thoracotomy and injury to the myocardium and apex, as well as potential for direct visualization of the aorta. In patients with specific high-risk comorbidities, such as chronic obstructive pulmonary disease and left ventricular systolic dysfunction, these advantages of the transaortic approach may result in superior [QoL].”
The transaortic approach “is indeed another option for most patients,” Dr. Block observed. But while it may entail less discomfort, he said, it still involves a thoracotomy. “However, its major attraction (especially in patients with diminished LV ejection fraction) is that a ventriculotomy is not needed,” he added.
Recovery following transaortic access is as good as after transfemoral, Dr. George noted, with “the added benefit of allowing early mobilization…. The procedure can be performed in almost all patients, unless a porcelain aorta exists, and may not have the same level of pulmonary impairment or pain that is seen after [transapical].
How to Optimize Transapical
As to strategies that may improve health-related QoL after transapical TAVR, Dr. Block said, “Theoretically, a ‘percutaneous’ [transapical] approach utilizing smaller delivery catheters and suitable/efficient closure technology… would have a great effect. Whether those technologies will evolve to practical application is still being researched.”
The study authors suggest that localized administration of anesthesia and the use of median sternotomy rather than thoracotomy could prove helpful. “However, these maneuvers do not eliminate the apical puncture and repair inherent to the [transapical] approach, which could adversely affect left ventricular function and cause subsequent functional limitation,” they say.
Dr. Cohen said that little research has been done on this topic but suggested minimizing rib spreading, perhaps by removing a rib prophylactically, or using local nerve blocks.
Note: Several coauthors on the paper are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.
Gada H, Kirtane AJ, Wang K, et al. Temporal trends in quality of life outcomes after transapical transcatheter aortic valve replacement: Placement of the AoRTic traNscathetER valve trial substudy. Circ Cardiovasc Qual Outcomes. 2015;Epub ahead of print.
- Dr. Cohen reports having received grant support, consulting fees, and speaking honoraria from several drug and device companies.
- Drs. Block and George report no relevant conflicts of interest.